<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/NCT03251222</url>
  </required_header>
  <id_info>
    <org_study_id>UKC-OCKL1</org_study_id>
    <nct_id>NCT03251222</nct_id>
  </id_info>
  <brief_title>Intranasal Sedation With Dexmedetomidine</brief_title>
  <official_title>Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For patients with eye surgery and shorter surgery, sedation is a well-established method in&#xD;
      preserved consciousness and has been successfully used for several years. We have also&#xD;
      developed and published a valid protocol (1).&#xD;
&#xD;
      Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a&#xD;
      descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is&#xD;
      important that the patient cooperates during the operation and should not be ashamed, as&#xD;
      injury to the eye could occur, because the vitrectomes are performed with a fine intraocular&#xD;
      endoscopic technique, in which the operator inserts his instruments through the whiteness&#xD;
      into the eye. For this reason, we have not yet added additional sedatives (for example,&#xD;
      midazolam), which is very unpredictable as regards sedation. Remifentanil is also very&#xD;
      unpredictable and it is very difficult to control it during the operation so that the patient&#xD;
      is saturated with satisfaction.&#xD;
&#xD;
      Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg&#xD;
      neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha&#xD;
      2 agonistic effect, which has not yet been used in the field of ocular surgery and has not&#xD;
      yet published articles in this field. The substance is very suitable because it works mildly&#xD;
      sedative and at the same time analgesic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For patients with eye surgery and shorter surgery, sedation is a well-established method in&#xD;
      preserved consciousness and has been successfully used for several years. We have also&#xD;
      developed and published a valid protocol (1).&#xD;
&#xD;
      Remifentanil is currently used for intravenous infusion for analgesia and anxiolysis.&#xD;
      Remifentanil is an opioid analgesic, which also works partially anxiolytically. It has been&#xD;
      studied in detail for postnatal analgesia (2). In eye surgery, it is important that the&#xD;
      patient cooperates during the operation and should not be ashamed, as injury to the eye could&#xD;
      occur, because the vitrectomes are performed with a fine intraocular endoscopic technique, in&#xD;
      which the operator inserts his instruments through the whiteness into the eye. For this&#xD;
      reason, we have not yet added additional sedatives (for example, midazolam), which is very&#xD;
      unpredictable and a rapidly shallow sedation can pass into the deeper. Remifentanil is also&#xD;
      very unpredictable and it is very difficult to control it during the operation, so that the&#xD;
      patient is satisfactorily analgesized at all times, but still co-operable.&#xD;
&#xD;
      Recently, dexmedetomidine (3-5) has been successfully used in other areas of surgery (eg&#xD;
      neurosurgery, maxillofacial surgery, ORL) and intensive sedation therapies. It is a safe,&#xD;
      proven, active substance with alpha 2 agonistic effect, which has not yet been used in the&#xD;
      field of ocular surgery and has not yet published articles in this field. The substance is&#xD;
      very suitable because it works mildly sedative and at the same time analgesic (3).&#xD;
&#xD;
      Dexmedetomidine is predominantly administered intravenously, and intranasal administration&#xD;
      (6-8) has also been established in pediatric patients.&#xD;
&#xD;
      We decided to use intranasal use because it is simple, safe and suitable for such treatments&#xD;
      because intravenous dexmedetomidine could not be administered because it should be given&#xD;
      enough time before surgery (at least 40 min) because otherwise the appropriate effect .&#xD;
      Patients for such operations will enter the operating room directly from the departments on&#xD;
      foot and dexmedetomidine could not be started earlier, as it is not possible to provide&#xD;
      adequate control in the department. A sedentary patient would also not be able to walk into&#xD;
      an operational one, which would greatly complicate and also increase logistics.&#xD;
&#xD;
      The study is applicable, as it will provide objective indicators, which type of sedation is&#xD;
      most effective and safe for vitreoretinal interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2017</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>remifentanil consuption</measure>
    <time_frame>duration of the procedure</time_frame>
    <description>the consuption of remifentanil requiered to reach the appropriate sedation will be meassured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxigen Saturation</measure>
    <time_frame>duration of the procedure</time_frame>
    <description>Oxigen Saturation measured with pulse oxymetry</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BIS- bispectral index</measure>
    <time_frame>duration of the procedure</time_frame>
    <description>Depth of the sedation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Conscious Sedation</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Concentrate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will recive 0.9% NaCl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Intranasal aplication of dexmedetomidine</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo - Concentrate</intervention_name>
    <description>Intranasal aplication of 0.9% NaCl</description>
    <arm_group_label>Placebo Concentrate</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: patients who will be operated on the eye (vitreoretinal interventions)&#xD;
        patients with ASA status 1-3&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who will not want to be operated in the sedation but in general anesthesia&#xD;
&#xD;
          -  poor general condition (ASA&gt; 3)&#xD;
&#xD;
          -  with severe cardiac disease (NYHA&gt; 3)&#xD;
&#xD;
          -  with severe pulmonary obstructive disease (FEV1 &lt;40%)&#xD;
&#xD;
          -  neurological diseases&#xD;
&#xD;
          -  psychiatric patients&#xD;
&#xD;
          -  patients receiving regular psychotropic treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vesna Novak-Jankovic, PROF</last_name>
    <role>Study Chair</role>
    <affiliation>UMCLjubljana, KOAIT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Iztok Potocnik, PHD</last_name>
    <phone>0038615228191</phone>
    <email>iztokpotocnik@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jasmina Markovic-Bozic, PHD</last_name>
    <phone>00386152218191</phone>
    <email>jasmina.markovic1@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UMCLjubljana, CD of Anaesthesiology and Intensive Therapy</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vesna Novak Jankovic, MD, PROF</last_name>
      <phone>+38615222930</phone>
      <email>vnovakjankovic@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Iztok Potocnik, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jasmina Markovic-Bozic, MD, PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dragana Markovic, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <results_reference>
    <citation>Ohashi Y, Baghirzada L, Sumikura H, Balki M. Erratum to: Remifentanil for labor analgesia: a comprehensive review. J Anesth. 2017 Feb;31(1):160. doi: 10.1007/s00540-016-2269-z. No abstract available.</citation>
    <PMID>27770212</PMID>
  </results_reference>
  <results_reference>
    <citation>Das S, Al-Mashani A, Suri N, Salhotra N, Chatterjee N. Combination of Continuous Dexmedetomidine Infusion with Titrated Ultra-Low-Dose Propofol-Fentanyl for an Awake Craniotomy. Sultan Qaboos Univ Med J. 2016 Aug;16(3):e347-51. doi: 10.18295/squmj.2016.16.03.014. Epub 2016 Aug 19.</citation>
    <PMID>27606116</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez-Simon A, Cacho-Asenjo E, Hernando B, Honorato-Cia C, Naval L, Panadero A, Nunez-Cordoba JM. Loading dose of Dexdor(R) and optimal sedation during oral and maxillofacial ambulatory surgery procedures: An observational study. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):206-213. doi: 10.1016/j.redar.2016.08.005. Epub 2016 Nov 5. English, Spanish.</citation>
    <PMID>27825666</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu J, Deng XM, Yang D, Wei LX, Zhi J, Xu WL, Liu JH. Comparison of Sedative Effects of Two Spray Administration of Intranasal Dexmedetomidine Doses for Premedication in Children. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2016 Oct 10;38(5):563-567. doi: 10.3881/j.issn.1000-503X.2016.05.013.</citation>
    <PMID>27825415</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghai B, Jain K, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.</citation>
    <PMID>27734549</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonanno LS, Pierce S, Badeaux J, FitzSimons JJ. Effectiveness of preoperative intranasal dexmedetomidine compared with oral midazolam for the prevention of emergence delirium in pediatric patients undergoing general anesthesia: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Aug;14(8):70-9. doi: 10.11124/JBISRIR-2016-003059.</citation>
    <PMID>27635747</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Iztok Potocnik</investigator_full_name>
    <investigator_title>M.D., PHD</investigator_title>
  </responsible_party>
  <keyword>conscious sedation, vitroretinal procedures</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03251222
org study id: UKC-OCKL1
nct id: NCT03251222
lead sponsor: 
has dmc: Yes
For patients with eye surgery and shorter surgery, sedation is a well-established method in
      preserved consciousness and has been successfully used for several years. We have also
      developed and published a valid protocol (1).

      Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a
      descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is
      important that the patient cooperates during the operation and should not be ashamed, as
      injury to the eye could occur, because the vitrectomes are performed with a fine intraocular
      endoscopic technique, in which the operator inserts his instruments through the whiteness
      into the eye. For this reason, we have not yet added additional sedatives (for example,
      midazolam), which is very unpredictable as regards sedation. Remifentanil is also very
      unpredictable and it is very difficult to control it during the operation so that the patient
      is saturated with satisfaction.

      Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg
      neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha
      2 agonistic effect, which has not yet been used in the field of ocular surgery and has not
      yet published articles in this field. The substance is very suitable because it works mildly
      sedative and at the same time analgesic.
For patients with eye surgery and shorter surgery, sedation is a well-established method in
      preserved consciousness and has been successfully used for several years. We have also
      developed and published a valid protocol (1).

      Remifentanil is currently used for intravenous infusion for analgesia and anxiolysis.
      Remifentanil is an opioid analgesic, which also works partially anxiolytically. It has been
      studied in detail for postnatal analgesia (2). In eye surgery, it is important that the
      patient cooperates during the operation and should not be ashamed, as injury to the eye could
      occur, because the vitrectomes are performed with a fine intraocular endoscopic technique, in
      which the operator inserts his instruments through the whiteness into the eye. For this
      reason, we have not yet added additional sedatives (for example, midazolam), which is very
      unpredictable and a rapidly shallow sedation can pass into the deeper. Remifentanil is also
      very unpredictable and it is very difficult to control it during the operation, so that the
      patient is satisfactorily analgesized at all times, but still co-operable.

      Recently, dexmedetomidine (3-5) has been successfully used in other areas of surgery (eg
      neurosurgery, maxillofacial surgery, ORL) and intensive sedation therapies. It is a safe,
      proven, active substance with alpha 2 agonistic effect, which has not yet been used in the
      field of ocular surgery and has not yet published articles in this field. The substance is
      very suitable because it works mildly sedative and at the same time analgesic (3).

      Dexmedetomidine is predominantly administered intravenously, and intranasal administration
      (6-8) has also been established in pediatric patients.

      We decided to use intranasal use because it is simple, safe and suitable for such treatments
      because intravenous dexmedetomidine could not be administered because it should be given
      enough time before surgery (at least 40 min) because otherwise the appropriate effect .
      Patients for such operations will enter the operating room directly from the departments on
      foot and dexmedetomidine could not be started earlier, as it is not possible to provide
      adequate control in the department. A sedentary patient would also not be able to walk into
      an operational one, which would greatly complicate and also increase logistics.

      The study is applicable, as it will provide objective indicators, which type of sedation is
      most effective and safe for vitreoretinal interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: remifentanil consuption
time frame: duration of the procedure
description: the consuption of remifentanil requiered to reach the appropriate sedation will be meassured
measure: Oxigen Saturation
time frame: duration of the procedure
description: Oxigen Saturation measured with pulse oxymetry
measure: BIS- bispectral index
time frame: duration of the procedure
description: Depth of the sedation
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil
arm group label: Placebo Concentrate
arm group type: Placebo Comparator
description: Patients will recive 0.9% NaCl
intervention type: Drug
intervention name: Dexmedetomidine
description: Intranasal aplication of dexmedetomidine
arm group label: Dexmedetomidine group
intervention type: Other
intervention name: Placebo - Concentrate
description: Intranasal aplication of 0.9% NaCl
arm group label: Placebo Concentrate
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vesna Novak-Jankovic, PROF
role: Study Chair
affiliation: UMCLjubljana, KOAIT
last name: Iztok Potocnik, PHD
phone: 0038615228191
email: iztokpotocnik@gmail.com
last name: Jasmina Markovic-Bozic, PHD
phone: 00386152218191
email: jasmina.markovic1@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Slovenia
citation: Ohashi Y, Baghirzada L, Sumikura H, Balki M. Erratum to: Remifentanil for labor analgesia: a comprehensive review. J Anesth. 2017 Feb;31(1):160. doi: 10.1007/s00540-016-2269-z. No abstract available.
PMID: 27770212
citation: Das S, Al-Mashani A, Suri N, Salhotra N, Chatterjee N. Combination of Continuous Dexmedetomidine Infusion with Titrated Ultra-Low-Dose Propofol-Fentanyl for an Awake Craniotomy. Sultan Qaboos Univ Med J. 2016 Aug;16(3):e347-51. doi: 10.18295/squmj.2016.16.03.014. Epub 2016 Aug 19.
PMID: 27606116
citation: Martinez-Simon A, Cacho-Asenjo E, Hernando B, Honorato-Cia C, Naval L, Panadero A, Nunez-Cordoba JM. Loading dose of Dexdor(R) and optimal sedation during oral and maxillofacial ambulatory surgery procedures: An observational study. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):206-213. doi: 10.1016/j.redar.2016.08.005. Epub 2016 Nov 5. English, Spanish.
PMID: 27825666
citation: Xu J, Deng XM, Yang D, Wei LX, Zhi J, Xu WL, Liu JH. Comparison of Sedative Effects of Two Spray Administration of Intranasal Dexmedetomidine Doses for Premedication in Children. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2016 Oct 10;38(5):563-567. doi: 10.3881/j.issn.1000-503X.2016.05.013.
PMID: 27825415
citation: Ghai B, Jain K, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.
PMID: 27734549
citation: Bonanno LS, Pierce S, Badeaux J, FitzSimons JJ. Effectiveness of preoperative intranasal dexmedetomidine compared with oral midazolam for the prevention of emergence delirium in pediatric patients undergoing general anesthesia: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Aug;14(8):70-9. doi: 10.11124/JBISRIR-2016-003059.
PMID: 27635747
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Iztok Potocnik
investigator title: M.D., PHD
mesh term: Dexmedetomidine