<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/NCT03775876</url>
  </required_header>
  <id_info>
    <org_study_id>CEHDF 945</org_study_id>
    <nct_id>NCT03775876</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy</brief_title>
  <official_title>Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint-Joseph University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint-Joseph University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Operative shoulder arthroscopy under regional block anesthesia often presents with&#xD;
      hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure&#xD;
      is required to minimize the bleeding. Regional anesthesia is successfully performed to many&#xD;
      patients in whom tracheal intubation or the placement of a laryngeal tube is undesired.&#xD;
      Propofol has traditionally been used to provide sedation in patients undergoing shoulder&#xD;
      arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly&#xD;
      selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and&#xD;
      anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on&#xD;
      blood pressure, the investigators set out to compare intraoperative hemodynamics of both&#xD;
      drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients&#xD;
      undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators&#xD;
      also assessed whether the type of anesthetic agent used for sedation accounted for other&#xD;
      differences in intra and post-operative outcome measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>
    <intervention_model_description>randomised controlled double blind trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>iSBP</measure>
    <time_frame>Hour 0</time_frame>
    <description>initial Systolic Blood Pressure (iSBP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>iMAP</measure>
    <time_frame>Hour 0</time_frame>
    <description>initial Mean Arterial blood Pressure (iMAP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SBP</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>Change in Systolic Blood Pressure from iSBP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>change in Mean Arterial blood Pressure from iMAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgeon Satisfaction: Global satisfaction scale</measure>
    <time_frame>up to 1 hour after surgery completion</time_frame>
    <description>Global satisfaction of the surgeon regarding anesthesia and patient immobility on a scale from 0 (not satisfied) to 10 (completely satisfied) collected at the end of surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of Bleeding</measure>
    <time_frame>up to 1 hour after surgery completion</time_frame>
    <description>Surgeon's evaluation of the bleeding that had affected the surgeon's visibility on a scale from 0 (no bleeding) to 5 (very intense bleeding) collected at the end of surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurence of Hypotension</measure>
    <time_frame>up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)</time_frame>
    <description>number of episodes of hypotension ( a drop of systolic blood pressure &gt;30% of the initial value recorded at patient arrival to the operating theatre)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RR</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>respiratory rate (RR) per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BPM</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>Beats per minute (BPM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SaO2</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>Oxygen Saturation (SaO2) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressors OR</measure>
    <time_frame>up to 0 minutes after admission to the PACU</time_frame>
    <description>use of vasoactive drugs during surgery (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressors PACU</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>use of vasoactive drugs during PACU stay (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tBIS</measure>
    <time_frame>up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>time to achieve desired Bispectral Index (tBIS) level (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PS1: scale</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Patient Satisfaction 1(PS1): I would want to have the same anesthetic again on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PS2: scale</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Patient Satisfaction 2(PS2): I felt pain on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PS3: scale</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Patient Satisfaction 3(PS3): I was satisfied with my anesthetic care on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PS4: scale</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Patient Satisfaction 4(PS4): I felt relaxed during the procedure on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PON</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POV</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for rescue analgesia: RA</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>need for rescue analgesia (RA) opioids at PACU (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALDRETE score</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>time to reach modified Aldrete score of 9/10 at PACU (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VASi</measure>
    <time_frame>up to 10 minutes after admission to the PACU</time_frame>
    <description>Visual Analog Scale initial (VASi): Visual analog rating scale for pain (VAS) in which 0 is defined as no pain and 10 as maximum pain at PACU arrival (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VASd</measure>
    <time_frame>up to 3 hours after surgery completion</time_frame>
    <description>Visual Analog Scale discharge (VASd): Visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain at PACU discharge (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Bradycardia</measure>
    <time_frame>up to 0 minutes after admission to the PACU</time_frame>
    <description>number of episodes of bradycardia (Heart rate &lt;45/min)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BIS level</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>Bispectral index (BIS) level value (0-100). BIS is used to monitor depth of anesthesia or sedation.The BIS is an electroencephalogram-derived multivariant scale.The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (Normal EEG activity or patient completely awake). 0 = EEG silence, [0 to 20] = burst suppression on EEG, [20 to 40] = deep hypnotic state, [40 to 60] = general anesthesia, [60 to 80] = sedation but individual responds to loud commands or mild shaking, [80 to 99] = sedation but individual responds to normal voice and 100 = Completely Awake.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ramsay sedation scale</measure>
    <time_frame>at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>Ramsay sedation scale value (1-6): 1=Anxious, agitated, restless; 2=Cooperative, oriented, tranquil; 3=Responsive to commands only; 4=Brisk response to light glabellar tap or loud auditory stimulus; 5=Sluggish response to light glabellar tap or loud auditory stimulus; 6=No response to light glabellar tap or loud auditory stimulus.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sedation Duration</measure>
    <time_frame>up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>total duration of Propofol or Dexmedetomidine infusion in minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Sedation Dose</measure>
    <time_frame>up to 0 minutes after the end of Propofol or Dexmedetomidine infusion</time_frame>
    <description>total dose of Propofol (mg) or Dexmedetomidine (mcg) used</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hemodynamic</condition>
  <condition>Sedation</condition>
  <condition>Satisfaction, Personal</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Shoulder Arthroscopy</intervention_name>
    <description>patients in both groups are programmed for an elective shoulder arthroscopy surgery</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional Block</intervention_name>
    <description>patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Interscalene brachial plexus block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>propofol 10mg/ml was used for sedation as described in the arms section</description>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Propofol-Lipuro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>BIS</intervention_name>
    <description>sedation level was monitored using bispectral index to achieve values described in the arms group</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>Bispectral index</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists score (ASA) I or II.&#xD;
&#xD;
          -  Elective Shoulder arthroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to any of the used medications.&#xD;
&#xD;
          -  ASA score of III or above.&#xD;
&#xD;
          -  Cardiac abnormalities.&#xD;
&#xD;
          -  Contraindications to regional blocks.&#xD;
&#xD;
          -  Patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hicham A ABOU ZEID, M.D., M.Sc.</last_name>
    <role>Study Chair</role>
    <affiliation>Saint Joseph University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nouhad S AYOUB, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Joseph University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hotel Dieu de France Hospital</name>
      <address>
        <city>Beirut</city>
        <zip>166830</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <reference>
    <citation>Peng K, Li J, Ji FH, Li Z. Dexmedetomidine compared with propofol for pediatric sedation during cerebral angiography. J Res Med Sci. 2014 Jun;19(6):549-54.</citation>
    <PMID>25197298</PMID>
  </reference>
  <reference>
    <citation>Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.</citation>
    <PMID>25834336</PMID>
  </reference>
  <reference>
    <citation>Wu Y, Zhang Y, Hu X, Qian C, Zhou Y, Xie J. A comparison of propofol vs. dexmedetomidine for sedation, haemodynamic control and satisfaction, during esophagogastroduodenoscopy under conscious sedation. J Clin Pharm Ther. 2015 Aug;40(4):419-25. doi: 10.1111/jcpt.12282. Epub 2015 May 13.</citation>
    <PMID>25970229</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint-Joseph University</investigator_affiliation>
    <investigator_full_name>Hicham Abou Zeid</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Propofol</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Regional anesthesia</keyword>
  <keyword>Satisfaction</keyword>
  <keyword>Shoulder arthroscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03775876
org study id: CEHDF 945
nct id: NCT03775876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Operative shoulder arthroscopy under regional block anesthesia often presents with
      hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure
      is required to minimize the bleeding. Regional anesthesia is successfully performed to many
      patients in whom tracheal intubation or the placement of a laryngeal tube is undesired.
      Propofol has traditionally been used to provide sedation in patients undergoing shoulder
      arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly
      selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and
      anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on
      blood pressure, the investigators set out to compare intraoperative hemodynamics of both
      drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients
      undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators
      also assessed whether the type of anesthetic agent used for sedation accounted for other
      differences in intra and post-operative outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomised controlled double blind trial
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)
measure: iSBP
time frame: Hour 0
description: initial Systolic Blood Pressure (iSBP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.
measure: iMAP
time frame: Hour 0
description: initial Mean Arterial blood Pressure (iMAP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.
measure: SBP
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: Change in Systolic Blood Pressure from iSBP
measure: MAP
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: change in Mean Arterial blood Pressure from iMAP
measure: Surgeon Satisfaction: Global satisfaction scale
time frame: up to 1 hour after surgery completion
description: Global satisfaction of the surgeon regarding anesthesia and patient immobility on a scale from 0 (not satisfied) to 10 (completely satisfied) collected at the end of surgery
measure: Estimation of Bleeding
time frame: up to 1 hour after surgery completion
description: Surgeon's evaluation of the bleeding that had affected the surgeon's visibility on a scale from 0 (no bleeding) to 5 (very intense bleeding) collected at the end of surgery
measure: Occurence of Hypotension
time frame: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)
description: number of episodes of hypotension ( a drop of systolic blood pressure >30% of the initial value recorded at patient arrival to the operating theatre)
measure: RR
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: respiratory rate (RR) per minute
measure: BPM
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: Beats per minute (BPM)
measure: SaO2
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: Oxygen Saturation (SaO2) (%)
measure: Vasopressors OR
time frame: up to 0 minutes after admission to the PACU
description: use of vasoactive drugs during surgery (Yes or No)
measure: Vasopressors PACU
time frame: up to 3 hours after surgery completion
description: use of vasoactive drugs during PACU stay (Yes or No)
measure: tBIS
time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: time to achieve desired Bispectral Index (tBIS) level (minutes)
measure: PS1: scale
time frame: up to 3 hours after surgery completion
description: Patient Satisfaction 1(PS1): I would want to have the same anesthetic again on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.
measure: PS2: scale
time frame: up to 3 hours after surgery completion
description: Patient Satisfaction 2(PS2): I felt pain on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.
measure: PS3: scale
time frame: up to 3 hours after surgery completion
description: Patient Satisfaction 3(PS3): I was satisfied with my anesthetic care on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.
measure: PS4: scale
time frame: up to 3 hours after surgery completion
description: Patient Satisfaction 4(PS4): I felt relaxed during the procedure on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.
measure: PON
time frame: up to 3 hours after surgery completion
description: Occurrence of Post Operative Nausea (PON) at PACU at least on episode (yes or No)
measure: POV
time frame: up to 3 hours after surgery completion
description: Occurence of Post Operative Vomiting (POV) at PACU at least on episode (yes or No)
measure: Need for rescue analgesia: RA
time frame: up to 3 hours after surgery completion
description: need for rescue analgesia (RA) opioids at PACU (Yes or No)
measure: ALDRETE score
time frame: up to 3 hours after surgery completion
description: time to reach modified Aldrete score of 9/10 at PACU (minutes)
measure: VASi
time frame: up to 10 minutes after admission to the PACU
description: Visual Analog Scale initial (VASi): Visual analog rating scale for pain (VAS) in which 0 is defined as no pain and 10 as maximum pain at PACU arrival (0-10)
measure: VASd
time frame: up to 3 hours after surgery completion
description: Visual Analog Scale discharge (VASd): Visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain at PACU discharge (0-10)
measure: Occurence of Bradycardia
time frame: up to 0 minutes after admission to the PACU
description: number of episodes of bradycardia (Heart rate <45/min)
measure: BIS level
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: Bispectral index (BIS) level value (0-100). BIS is used to monitor depth of anesthesia or sedation.The BIS is an electroencephalogram-derived multivariant scale.The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (Normal EEG activity or patient completely awake). 0 = EEG silence, [0 to 20] = burst suppression on EEG, [20 to 40] = deep hypnotic state, [40 to 60] = general anesthesia, [60 to 80] = sedation but individual responds to loud commands or mild shaking, [80 to 99] = sedation but individual responds to normal voice and 100 = Completely Awake.
measure: Ramsay sedation scale
time frame: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: Ramsay sedation scale value (1-6): 1=Anxious, agitated, restless; 2=Cooperative, oriented, tranquil; 3=Responsive to commands only; 4=Brisk response to light glabellar tap or loud auditory stimulus; 5=Sluggish response to light glabellar tap or loud auditory stimulus; 6=No response to light glabellar tap or loud auditory stimulus.
measure: Sedation Duration
time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: total duration of Propofol or Dexmedetomidine infusion in minutes
measure: Sedation Dose
time frame: up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
description: total dose of Propofol (mg) or Dexmedetomidine (mcg) used
arm group label: Propofol
arm group type: Active Comparator
description: Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.
arm group label: Dexmedetomidine
arm group type: Active Comparator
description: Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.
intervention type: Procedure
intervention name: Shoulder Arthroscopy
description: patients in both groups are programmed for an elective shoulder arthroscopy surgery
arm group label: Dexmedetomidine
arm group label: Propofol
other name: Surgery
intervention type: Procedure
intervention name: Regional Block
description: patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.
arm group label: Dexmedetomidine
arm group label: Propofol
other name: Interscalene brachial plexus block
intervention type: Drug
intervention name: Propofol
description: propofol 10mg/ml was used for sedation as described in the arms section
arm group label: Propofol
other name: Propofol-Lipuro
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section
arm group label: Dexmedetomidine
other name: Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj
intervention type: Diagnostic Test
intervention name: BIS
description: sedation level was monitored using bispectral index to achieve values described in the arms group
arm group label: Dexmedetomidine
arm group label: Propofol
other name: Bispectral index
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hicham A ABOU ZEID, M.D., M.Sc.
role: Study Chair
affiliation: Saint Joseph University School of Medicine
last name: Nouhad S AYOUB, M.D.
role: Principal Investigator
affiliation: Saint Joseph University School of Medicine
facility: 
country: Lebanon
citation: Peng K, Li J, Ji FH, Li Z. Dexmedetomidine compared with propofol for pediatric sedation during cerebral angiography. J Res Med Sci. 2014 Jun;19(6):549-54.
PMID: 25197298
citation: Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.
PMID: 25834336
citation: Wu Y, Zhang Y, Hu X, Qian C, Zhou Y, Xie J. A comparison of propofol vs. dexmedetomidine for sedation, haemodynamic control and satisfaction, during esophagogastroduodenoscopy under conscious sedation. J Clin Pharm Ther. 2015 Aug;40(4):419-25. doi: 10.1111/jcpt.12282. Epub 2015 May 13.
PMID: 25970229
responsible party type: Principal Investigator
investigator affiliation: Saint-Joseph University
investigator full name: Hicham Abou Zeid
investigator title: Assistant Professor
mesh term: Dexmedetomidine
mesh term: Propofol
sharing ipd: No