<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255824</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6953</org_study_id>
    <nct_id>NCT03255824</nct_id>
  </id_info>
  <brief_title>A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation</brief_title>
  <official_title>A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar&#xD;
      surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and&#xD;
      3) no significant hemodynamic or respiratory changes when compared to a sedation combination&#xD;
      of midazolam, fentanyl and propofol for sedation during third molar surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous sedation (IVS) is an integral aspect of the oral and maxillofacial surgeon's&#xD;
      practice. For many minor oral surgical procedures, intravenous sedation is often necessary to&#xD;
      manage patient anxiety and discomfort, while also facilitating a safe and efficient procedure&#xD;
      in the outpatient setting. Ideally, sedative agents have anxiolytic, amnestic, and analgesic&#xD;
      properties while maintaining cardiopulmonary stability. The medications used should allow for&#xD;
      rapid onset of action, as well as a quick recovery, with minimal side effects.&#xD;
&#xD;
      Several pharmacologic agents are frequently used for conscious sedation in the oral surgery&#xD;
      practice. These medications often include midazolam, fentanyl, ketamine and propofol, either&#xD;
      alone or in conjunction with one another. While propofol and fentanyl have proved to be&#xD;
      efficacious agents for use in intravenous sedation, they are not without associated side&#xD;
      effects. Propofol has the potential to cause a quick progression from conscious sedation to&#xD;
      general anesthesia, with the undesired effect of associated cardiovascular and respiratory&#xD;
      depression. Decreased respiratory drive, hypotension, and dose-dependent bradycardia are&#xD;
      often seen with opioid analgesics such as fentanyl.1,2 Ketamine can cause emergence delirium,&#xD;
      increased salivation and pulmonary secretions, tachycardia, and post-operative nausea and&#xD;
      vomiting (PONV).&#xD;
&#xD;
      Midazolam is a benzodiazepine that is an attractive agent for intravenous sedation due to its&#xD;
      sedative, amnestic, and hypnotic properties. In addition, it is associated with very minimal&#xD;
      cardiovascular and respiratory changes. However, midazolam lacks significant analgesic&#xD;
      effects, and therefore is routinely used in conjunction with additional agents when used for&#xD;
      procedural sedation. Though several studies have explored the use of midazolam as a sole&#xD;
      anesthetic, very high doses are required for deep sedation. This can lead to dose-dependent&#xD;
      respiratory depression, prolonged emergence and longer recovery time.&#xD;
&#xD;
      Dexmedetomidine (Precedex, Hospira, Inc., Lake Forest, IL) is a highly selective&#xD;
      alpha2-adrenergic agonist that possesses hypnotic, sedative, anxiolytic, and analgesic&#xD;
      properties. It is currently approved for use as a sedative agent in ICU patients, and has&#xD;
      been proven a safe and effective agent for use during procedural sedation. In the central&#xD;
      nervous system, the primary site of action of dexmedetomidine is the locus ceruleus,&#xD;
      resulting in a level of sedation similar to natural sleep, associated with fast and easy&#xD;
      arousal. It demonstrates relative hemodynamic stability with little effect on respiratory&#xD;
      depression. Unlike propofol and fentanyl, dexmedetomidine's lack of adverse effects on&#xD;
      respiration makes it an attractive agent for use during intravenous sedation in the oral and&#xD;
      maxillofacial surgery practice.&#xD;
&#xD;
      Several studies involving dexmedetomidine exist in the oral and maxillofacial surgery&#xD;
      literature. Dexmedetomidine has been compared as a substitute for midazolam, as well as&#xD;
      propofol, in conscious sedation by several authors. For third molar surgery, dexmedetomidine&#xD;
      was noted to preserve the respiratory rate and oxygen saturation throughout operation and&#xD;
      recovery periods. Fan et al also found no significant differences in respiratory rate when&#xD;
      comparing the two agents for conscious sedation. In comparison to midazolam, Ryu et al&#xD;
      reported safe sedation without airway compromise and minimal effects on the respiratory&#xD;
      system.&#xD;
&#xD;
      Dexmedetomidine also possesses sympatholytic properties, and is commonly associated with a&#xD;
      dose-dependent decrease in both heart rate and blood pressure.4,9 Taniyama et al compared&#xD;
      dexmedetomidine to propofol for intravenous sedation for minor oral surgical procedures. They&#xD;
      found that dexmedetomidine lead to significant hemodynamic changes during the initial loading&#xD;
      infusion. An initial increase in blood pressure was seen, followed by a significant decrease&#xD;
      in both systolic and diastolic blood pressure, as well as heart rate. These variations are&#xD;
      attributed to the fact that dexmedetomidine does not have selectivity for alpha-2A versus&#xD;
      alpha-2B receptors. While alpha-2A receptors are found in the CNS and are therefore&#xD;
      responsible for the analgesic and sedative effects of the drug, alpha-2B receptors are found&#xD;
      in vascular smooth muscle and thereby mediate the hypertensive effects of high doses of&#xD;
      dexmedetomidine. Because of this, initial loading doses of dexmedetomidine may be associated&#xD;
      with a transient increase in blood pressure, followed by an overall reduction in blood&#xD;
      pressure and heart rate from baseline. Hall et al reported that dexmedetomidine demonstrated&#xD;
      a decrease in heart rate from baseline between 16 and 18%, and a decrease in blood pressure&#xD;
      of 10 to 20%.15 However, in some studies, similar biphasic changes were not observed,&#xD;
      possibly due to the use of a lower dosage of dexmedetomidine.&#xD;
&#xD;
      Aside from dose-dependent depression of the cardiovascular system, dexmedetomidine has been&#xD;
      associated with minimal to no amnesic effects. One other possible disadvantage of&#xD;
      dexmedetomidine as a sedative agent for in-office procedures is the increased postoperative&#xD;
      recovery time. Peak sedative effects of the drug occur approximately 90-105 minutes after&#xD;
      administration, continuing to as much as 180 minutes. This may necessitate post-operative&#xD;
      observation periods of increased duration. Intravenously administered dexmedetomidine has a&#xD;
      distribution half-life of 6 minutes and an elimination half-life of 2 hours. It undergoes&#xD;
      biotransformation in the liver and is excreted primarily in the urine.&#xD;
&#xD;
      The purpose of this study is to measure the relative efficacy (sedation, analgesia, operating&#xD;
      conditions, and patient satisfaction) and safety (hemodynamic and respiratory changes) of&#xD;
      dexmedetomidine and midazolam compared to the traditional combination of midazolam, fentanyl,&#xD;
      and propofol in office based intravenous sedation for extraction of third molars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 23, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Events Requiring Intervention</measure>
    <time_frame>During surgery</time_frame>
    <description>To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reaction to Administration of Local Anesthesia</measure>
    <time_frame>During the first injection of local anesthesia during surgery</time_frame>
    <description>To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.&#xD;
The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>30 minutes following surgery</time_frame>
    <description>Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.&#xD;
The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).&#xD;
A higher score is a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon Satisfaction - Survey</measure>
    <time_frame>15 minutes following surgery</time_frame>
    <description>Surgeon satisfaction was measured by the surgeon grading the &quot;Operating Conditions&quot; scale.&#xD;
The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooperation Scale</measure>
    <time_frame>15 minutes following surgery</time_frame>
    <description>Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Stability - Heart Rate</measure>
    <time_frame>During the procedure, up to 40 minutes</time_frame>
    <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)&#xD;
a. Change in heart rate (change ≥ 20 BPM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Stability - Blood Pressure</measure>
    <time_frame>During the procedure, up to 40 minutes</time_frame>
    <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)&#xD;
a. Change in blood pressure (NIBP) (change ≥ 20%) Blood pressure is presented as mean arterial pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Depression - Respiratory Rate</measure>
    <time_frame>During the procedure, up to 40 minutes</time_frame>
    <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in respiratory rate (change ≥ 20%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Depression - Oxygen Saturation</measure>
    <time_frame>During the procedure, up to 40 minutes</time_frame>
    <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Recovery Time - Duration of Procedure</measure>
    <time_frame>During the procedure, up to 40 minutes</time_frame>
    <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Duration of procedure will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Recovery Time - Ambulation</measure>
    <time_frame>After the procedure until ambulation, up to 20 minutes</time_frame>
    <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to ambulation (to recovery room) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Recovery Time - Time to Discharge</measure>
    <time_frame>After the procedure until discharge, up to 45 minutes</time_frame>
    <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to discharge or &quot;virtual discharge&quot; (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate.&#xD;
ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the &quot;virtual discharge&quot; time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Propofol Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine and Midazolam</intervention_name>
    <description>Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
    <arm_group_label>Dexmedetomidine Group</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol, Midazolam, and Fentanyl</intervention_name>
    <description>Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
    <arm_group_label>Propofol Group</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have 3-4 partial or full bony impacted third molars requiring surgical&#xD;
             extraction&#xD;
&#xD;
          -  ASA Class I or II&#xD;
&#xD;
          -  English-speaking and Spanish-speaking subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA Class III or higher&#xD;
&#xD;
          -  Patients taking alpha-2 agonists or benzodiazepines&#xD;
&#xD;
          -  Allergy or drug reaction to any of the drugs used in this study (benzodiazepines,&#xD;
             opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)&#xD;
&#xD;
          -  BMI greater than 30&#xD;
&#xD;
          -  History of or current substance abuse or alcoholism&#xD;
&#xD;
          -  History of mood-altering medications, tranquilizers, or antidepressants.&#xD;
&#xD;
          -  Pregnant females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Roback MG, Wathen JE, MacKenzie T, Bajaj L. A randomized, controlled trial of i.v. versus i.m. ketamine for sedation of pediatric patients receiving emergency department orthopedic procedures. Ann Emerg Med. 2006 Nov;48(5):605-12. doi: 10.1016/j.annemergmed.2006.06.001. Epub 2006 Aug 14.</citation>
    <PMID>17052563</PMID>
  </reference>
  <reference>
    <citation>Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009.</citation>
    <PMID>15930401</PMID>
  </reference>
  <reference>
    <citation>Barone CP, Pablo CS, Barone GW. Postanesthetic care in the critical care unit. Crit Care Nurse. 2004 Feb;24(1):38-45. No abstract available.</citation>
    <PMID>15007891</PMID>
  </reference>
  <reference>
    <citation>Eberl S, Preckel B, Bergman JJ, Hollmann MW. Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial. BMC Gastroenterol. 2013 Dec 30;13:176. doi: 10.1186/1471-230X-13-176.</citation>
    <PMID>24377675</PMID>
  </reference>
  <reference>
    <citation>Parworth LP, Frost DE, Zuniga JR, Bennett T. Propofol and fentanyl compared with midazolam and fentanyl during third molar surgery. J Oral Maxillofac Surg. 1998 Apr;56(4):447-53; discussion 453-4. doi: 10.1016/s0278-2391(98)90710-8. Erratum In: J Oral Maxillofac Surg. 1999 Feb;57(2):219.</citation>
    <PMID>9541344</PMID>
  </reference>
  <reference>
    <citation>Jun NH, Shim JK, Choi YS, An SH, Kwak YL. Effect of ketamine pretreatment for anaesthesia in patients undergoing percutaneous transluminal balloon angioplasty with continuous remifentanil infusion. Korean J Anesthesiol. 2011 Oct;61(4):308-14. doi: 10.4097/kjae.2011.61.4.308. Epub 2011 Oct 22.</citation>
    <PMID>22110884</PMID>
  </reference>
  <reference>
    <citation>Ustun Y, Gunduz M, Erdogan O, Benlidayi ME. Dexmedetomidine versus midazolam in outpatient third molar surgery. J Oral Maxillofac Surg. 2006 Sep;64(9):1353-8. doi: 10.1016/j.joms.2006.05.020.</citation>
    <PMID>16916668</PMID>
  </reference>
  <reference>
    <citation>Fan TW, Ti LK, Islam I. Comparison of dexmedetomidine and midazolam for conscious sedation in dental surgery monitored by bispectral index. Br J Oral Maxillofac Surg. 2013 Jul;51(5):428-33. doi: 10.1016/j.bjoms.2012.08.013. Epub 2012 Oct 8.</citation>
    <PMID>23058230</PMID>
  </reference>
  <reference>
    <citation>Makary L, Vornik V, Finn R, Lenkovsky F, McClelland AL, Thurmon J, Robertson B. Prolonged recovery associated with dexmedetomidine when used as a sole sedative agent in office-based oral and maxillofacial surgery procedures. J Oral Maxillofac Surg. 2010 Feb;68(2):386-91. doi: 10.1016/j.joms.2009.09.107.</citation>
    <PMID>20116712</PMID>
  </reference>
  <reference>
    <citation>Cheung CW, Ying CL, Chiu WK, Wong GT, Ng KF, Irwin MG. A comparison of dexmedetomidine and midazolam for sedation in third molar surgery. Anaesthesia. 2007 Nov;62(11):1132-8. doi: 10.1111/j.1365-2044.2007.05230.x.</citation>
    <PMID>17924894</PMID>
  </reference>
  <reference>
    <citation>Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.</citation>
    <PMID>21685111</PMID>
  </reference>
  <reference>
    <citation>Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.</citation>
    <PMID>10730549</PMID>
  </reference>
  <reference>
    <citation>Jaakola ML. Dexmedetomidine premedication before intravenous regional anesthesia in minor outpatient hand surgery. J Clin Anesth. 1994 May-Jun;6(3):204-11. doi: 10.1016/0952-8180(94)90060-4.</citation>
    <PMID>7914737</PMID>
  </reference>
  <reference>
    <citation>Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.</citation>
    <PMID>23497981</PMID>
  </reference>
  <reference>
    <citation>Smiley MK, Prior SR. Dexmedetomidine sedation with and without midazolam for third molar surgery. Anesth Prog. 2014 Spring;61(1):3-10. doi: 10.2344/0003-3006-61.1.3.</citation>
    <PMID>24697819</PMID>
  </reference>
  <reference>
    <citation>Ryu DS, Lee DW, Choi SC, Oh IH. Sedation Protocol Using Dexmedetomidine for Third Molar Extraction. J Oral Maxillofac Surg. 2016 May;74(5):926.e1-7. doi: 10.1016/j.joms.2015.12.021. Epub 2016 Jan 7.</citation>
    <PMID>26850877</PMID>
  </reference>
  <reference>
    <citation>Taniyama K, Oda H, Okawa K, Himeno K, Shikanai K, Shibutani T. Psychosedation with dexmedetomidine hydrochloride during minor oral surgery. Anesth Prog. 2009 Autumn;56(3):75-80. doi: 10.2344/0003-3006-56.3.75.</citation>
    <PMID>19769420</PMID>
  </reference>
  <reference>
    <citation>Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.</citation>
    <PMID>10702460</PMID>
  </reference>
  <reference>
    <citation>Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.</citation>
    <PMID>19697008</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>March 23, 2020</results_first_submitted>
  <results_first_submitted_qc>April 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2020</results_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Patrick Nolan</investigator_full_name>
    <investigator_title>Attending Oral Maxillofacial Surgery</investigator_title>
  </responsible_party>
  <keyword>Oral Surgery</keyword>
  <keyword>Third Molars</keyword>
  <keyword>Intravenous Sedation</keyword>
  <keyword>Dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03255824/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Propofol Group</title>
          <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
        </group>
        <group group_id="P2">
          <title>Dexmedetomidine Group</title>
          <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Under-sedation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Propofol Group</title>
          <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
        </group>
        <group group_id="B2">
          <title>Dexmedetomidine Group</title>
          <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
            <count group_id="B2" value="75"/>
            <count group_id="B3" value="144"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.3" spread="2.7"/>
                    <measurement group_id="B2" value="21.4" spread="2.5"/>
                    <measurement group_id="B3" value="21.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Race/Ethnicity Not Collected</description>
          <population>Race/Ethnicity Not Collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3" spread="5.2"/>
                    <measurement group_id="B2" value="26.1" spread="5.4"/>
                    <measurement group_id="B3" value="25.7" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Impactions</title>
          <units>Impacted Teeth</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="0.5"/>
                    <measurement group_id="B2" value="3.6" spread="0.5"/>
                    <measurement group_id="B3" value="3.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Events Requiring Intervention</title>
        <description>To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.</description>
        <time_frame>During surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Events Requiring Intervention</title>
          <description>To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reaction to Administration of Local Anesthesia</title>
        <description>To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.&#xD;
The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)</description>
        <time_frame>During the first injection of local anesthesia during surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Reaction to Administration of Local Anesthesia</title>
          <description>To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.&#xD;
The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="1.5"/>
                    <measurement group_id="O2" value="4.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.&#xD;
The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).&#xD;
A higher score is a better outcome.</description>
        <time_frame>30 minutes following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.&#xD;
The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).&#xD;
A higher score is a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5" spread="10.1"/>
                    <measurement group_id="O2" value="86.6" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Satisfaction - Survey</title>
        <description>Surgeon satisfaction was measured by the surgeon grading the &quot;Operating Conditions&quot; scale.&#xD;
The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good</description>
        <time_frame>15 minutes following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Satisfaction - Survey</title>
          <description>Surgeon satisfaction was measured by the surgeon grading the &quot;Operating Conditions&quot; scale.&#xD;
The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.5"/>
                    <measurement group_id="O2" value="2.9" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooperation Scale</title>
        <description>Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)</description>
        <time_frame>15 minutes following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooperation Scale</title>
          <description>Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.07" spread="1.95"/>
                    <measurement group_id="O2" value="1.47" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Stability - Heart Rate</title>
        <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)&#xD;
a. Change in heart rate (change ≥ 20 BPM)</description>
        <time_frame>During the procedure, up to 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Stability - Heart Rate</title>
          <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)&#xD;
a. Change in heart rate (change ≥ 20 BPM)</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" spread="14.20"/>
                    <measurement group_id="O2" value="62" spread="12.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Stability - Blood Pressure</title>
        <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)&#xD;
a. Change in blood pressure (NIBP) (change ≥ 20%) Blood pressure is presented as mean arterial pressure</description>
        <time_frame>During the procedure, up to 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Stability - Blood Pressure</title>
          <description>To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)&#xD;
a. Change in blood pressure (NIBP) (change ≥ 20%) Blood pressure is presented as mean arterial pressure</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="12.4"/>
                    <measurement group_id="O2" value="88" spread="9.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Depression - Respiratory Rate</title>
        <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in respiratory rate (change ≥ 20%)</description>
        <time_frame>During the procedure, up to 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Depression - Respiratory Rate</title>
          <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in respiratory rate (change ≥ 20%)</description>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" spread="4.38"/>
                    <measurement group_id="O2" value="18" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Depression - Oxygen Saturation</title>
        <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%</description>
        <time_frame>During the procedure, up to 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Depression - Oxygen Saturation</title>
          <description>To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.&#xD;
a. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%</description>
          <units>Saturation percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" spread="1.03"/>
                    <measurement group_id="O2" value="98.9" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Recovery Time - Duration of Procedure</title>
        <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Duration of procedure will be recorded</description>
        <time_frame>During the procedure, up to 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Recovery Time - Duration of Procedure</title>
          <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Duration of procedure will be recorded</description>
          <units>MINUTES</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" spread="13.9"/>
                    <measurement group_id="O2" value="22.1" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Recovery Time - Ambulation</title>
        <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to ambulation (to recovery room) will be recorded</description>
        <time_frame>After the procedure until ambulation, up to 20 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Recovery Time - Ambulation</title>
          <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to ambulation (to recovery room) will be recorded</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="8.6"/>
                    <measurement group_id="O2" value="11.6" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Recovery Time - Time to Discharge</title>
        <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to discharge or &quot;virtual discharge&quot; (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate.&#xD;
ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the &quot;virtual discharge&quot; time</description>
        <time_frame>After the procedure until discharge, up to 45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol Group</title>
            <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
          </group>
          <group group_id="O2">
            <title>Dexmedetomidine Group</title>
            <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Recovery Time - Time to Discharge</title>
          <description>To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.&#xD;
a. Time to discharge or &quot;virtual discharge&quot; (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate.&#xD;
ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the &quot;virtual discharge&quot; time</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" spread="14.9"/>
                    <measurement group_id="O2" value="29.9" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Propofol Group</title>
          <description>Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.&#xD;
Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.</description>
        </group>
        <group group_id="E2">
          <title>Dexmedetomidine Group</title>
          <description>Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.&#xD;
Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Patrick Nolan</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>718-405-8195</phone>
      <email>pnolan@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255824
org study id: 2016-6953
nct id: NCT03255824
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar
      surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and
      3) no significant hemodynamic or respiratory changes when compared to a sedation combination
      of midazolam, fentanyl and propofol for sedation during third molar surgery.
Intravenous sedation (IVS) is an integral aspect of the oral and maxillofacial surgeon's
      practice. For many minor oral surgical procedures, intravenous sedation is often necessary to
      manage patient anxiety and discomfort, while also facilitating a safe and efficient procedure
      in the outpatient setting. Ideally, sedative agents have anxiolytic, amnestic, and analgesic
      properties while maintaining cardiopulmonary stability. The medications used should allow for
      rapid onset of action, as well as a quick recovery, with minimal side effects.

      Several pharmacologic agents are frequently used for conscious sedation in the oral surgery
      practice. These medications often include midazolam, fentanyl, ketamine and propofol, either
      alone or in conjunction with one another. While propofol and fentanyl have proved to be
      efficacious agents for use in intravenous sedation, they are not without associated side
      effects. Propofol has the potential to cause a quick progression from conscious sedation to
      general anesthesia, with the undesired effect of associated cardiovascular and respiratory
      depression. Decreased respiratory drive, hypotension, and dose-dependent bradycardia are
      often seen with opioid analgesics such as fentanyl.1,2 Ketamine can cause emergence delirium,
      increased salivation and pulmonary secretions, tachycardia, and post-operative nausea and
      vomiting (PONV).

      Midazolam is a benzodiazepine that is an attractive agent for intravenous sedation due to its
      sedative, amnestic, and hypnotic properties. In addition, it is associated with very minimal
      cardiovascular and respiratory changes. However, midazolam lacks significant analgesic
      effects, and therefore is routinely used in conjunction with additional agents when used for
      procedural sedation. Though several studies have explored the use of midazolam as a sole
      anesthetic, very high doses are required for deep sedation. This can lead to dose-dependent
      respiratory depression, prolonged emergence and longer recovery time.

      Dexmedetomidine (Precedex, Hospira, Inc., Lake Forest, IL) is a highly selective
      alpha2-adrenergic agonist that possesses hypnotic, sedative, anxiolytic, and analgesic
      properties. It is currently approved for use as a sedative agent in ICU patients, and has
      been proven a safe and effective agent for use during procedural sedation. In the central
      nervous system, the primary site of action of dexmedetomidine is the locus ceruleus,
      resulting in a level of sedation similar to natural sleep, associated with fast and easy
      arousal. It demonstrates relative hemodynamic stability with little effect on respiratory
      depression. Unlike propofol and fentanyl, dexmedetomidine's lack of adverse effects on
      respiration makes it an attractive agent for use during intravenous sedation in the oral and
      maxillofacial surgery practice.

      Several studies involving dexmedetomidine exist in the oral and maxillofacial surgery
      literature. Dexmedetomidine has been compared as a substitute for midazolam, as well as
      propofol, in conscious sedation by several authors. For third molar surgery, dexmedetomidine
      was noted to preserve the respiratory rate and oxygen saturation throughout operation and
      recovery periods. Fan et al also found no significant differences in respiratory rate when
      comparing the two agents for conscious sedation. In comparison to midazolam, Ryu et al
      reported safe sedation without airway compromise and minimal effects on the respiratory
      system.

      Dexmedetomidine also possesses sympatholytic properties, and is commonly associated with a
      dose-dependent decrease in both heart rate and blood pressure.4,9 Taniyama et al compared
      dexmedetomidine to propofol for intravenous sedation for minor oral surgical procedures. They
      found that dexmedetomidine lead to significant hemodynamic changes during the initial loading
      infusion. An initial increase in blood pressure was seen, followed by a significant decrease
      in both systolic and diastolic blood pressure, as well as heart rate. These variations are
      attributed to the fact that dexmedetomidine does not have selectivity for alpha-2A versus
      alpha-2B receptors. While alpha-2A receptors are found in the CNS and are therefore
      responsible for the analgesic and sedative effects of the drug, alpha-2B receptors are found
      in vascular smooth muscle and thereby mediate the hypertensive effects of high doses of
      dexmedetomidine. Because of this, initial loading doses of dexmedetomidine may be associated
      with a transient increase in blood pressure, followed by an overall reduction in blood
      pressure and heart rate from baseline. Hall et al reported that dexmedetomidine demonstrated
      a decrease in heart rate from baseline between 16 and 18%, and a decrease in blood pressure
      of 10 to 20%.15 However, in some studies, similar biphasic changes were not observed,
      possibly due to the use of a lower dosage of dexmedetomidine.

      Aside from dose-dependent depression of the cardiovascular system, dexmedetomidine has been
      associated with minimal to no amnesic effects. One other possible disadvantage of
      dexmedetomidine as a sedative agent for in-office procedures is the increased postoperative
      recovery time. Peak sedative effects of the drug occur approximately 90-105 minutes after
      administration, continuing to as much as 180 minutes. This may necessitate post-operative
      observation periods of increased duration. Intravenously administered dexmedetomidine has a
      distribution half-life of 6 minutes and an elimination half-life of 2 hours. It undergoes
      biotransformation in the liver and is excreted primarily in the urine.

      The purpose of this study is to measure the relative efficacy (sedation, analgesia, operating
      conditions, and patient satisfaction) and safety (hemodynamic and respiratory changes) of
      dexmedetomidine and midazolam compared to the traditional combination of midazolam, fentanyl,
      and propofol in office based intravenous sedation for extraction of third molars.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Respiratory Events Requiring Intervention
time frame: During surgery
description: To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.
measure: Reaction to Administration of Local Anesthesia
time frame: During the first injection of local anesthesia during surgery
description: To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.
The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)
measure: Patient Satisfaction
time frame: 30 minutes following surgery
description: Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.
The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).
A higher score is a better outcome.
measure: Surgeon Satisfaction - Survey
time frame: 15 minutes following surgery
description: Surgeon satisfaction was measured by the surgeon grading the "Operating Conditions" scale.
The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good
measure: Cooperation Scale
time frame: 15 minutes following surgery
description: Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)
measure: Hemodynamic Stability - Heart Rate
time frame: During the procedure, up to 40 minutes
description: To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)
a. Change in heart rate (change ≥ 20 BPM)
measure: Hemodynamic Stability - Blood Pressure
time frame: During the procedure, up to 40 minutes
description: To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)
a. Change in blood pressure (NIBP) (change ≥ 20%) Blood pressure is presented as mean arterial pressure
measure: Respiratory Depression - Respiratory Rate
time frame: During the procedure, up to 40 minutes
description: To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.
a. Change in respiratory rate (change ≥ 20%)
measure: Respiratory Depression - Oxygen Saturation
time frame: During the procedure, up to 40 minutes
description: To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.
a. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%
measure: Postoperative Recovery Time - Duration of Procedure
time frame: During the procedure, up to 40 minutes
description: To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.
a. Duration of procedure will be recorded
measure: Postoperative Recovery Time - Ambulation
time frame: After the procedure until ambulation, up to 20 minutes
description: To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.
a. Time to ambulation (to recovery room) will be recorded
measure: Postoperative Recovery Time - Time to Discharge
time frame: After the procedure until discharge, up to 45 minutes
description: To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.
a. Time to discharge or "virtual discharge" (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate.
ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the "virtual discharge" time
arm group label: Propofol Group
arm group type: Active Comparator
description: Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.
arm group label: Dexmedetomidine Group
arm group type: Experimental
description: Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.
intervention type: Drug
intervention name: Dexmedetomidine and Midazolam
description: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
arm group label: Dexmedetomidine Group
other name: Precedex
intervention type: Drug
intervention name: Propofol, Midazolam, and Fentanyl
description: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.
arm group label: Propofol Group
other name: Diprivan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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PMID: 17052563
citation: Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. doi: 10.1197/j.aem.2004.12.009.
PMID: 15930401
citation: Barone CP, Pablo CS, Barone GW. Postanesthetic care in the critical care unit. Crit Care Nurse. 2004 Feb;24(1):38-45. No abstract available.
PMID: 15007891
citation: Eberl S, Preckel B, Bergman JJ, Hollmann MW. Safety and effectiveness using dexmedetomidine versus propofol TCI sedation during oesophagus interventions: a randomized trial. BMC Gastroenterol. 2013 Dec 30;13:176. doi: 10.1186/1471-230X-13-176.
PMID: 24377675
citation: Parworth LP, Frost DE, Zuniga JR, Bennett T. Propofol and fentanyl compared with midazolam and fentanyl during third molar surgery. J Oral Maxillofac Surg. 1998 Apr;56(4):447-53; discussion 453-4. doi: 10.1016/s0278-2391(98)90710-8. Erratum In: J Oral Maxillofac Surg. 1999 Feb;57(2):219.
PMID: 9541344
citation: Jun NH, Shim JK, Choi YS, An SH, Kwak YL. Effect of ketamine pretreatment for anaesthesia in patients undergoing percutaneous transluminal balloon angioplasty with continuous remifentanil infusion. Korean J Anesthesiol. 2011 Oct;61(4):308-14. doi: 10.4097/kjae.2011.61.4.308. Epub 2011 Oct 22.
PMID: 22110884
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PMID: 16916668
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PMID: 23058230
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PMID: 20116712
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PMID: 17924894
citation: Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
PMID: 21685111
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PMID: 10730549
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citation: Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
PMID: 23497981
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PMID: 10702460
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PMID: 19697008
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Patrick Nolan
investigator title: Attending Oral Maxillofacial Surgery
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 