<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/NCT04452383</url>
  </required_header>
  <id_info>
    <org_study_id>Sedation in DISE</org_study_id>
    <nct_id>NCT04452383</nct_id>
  </id_info>
  <brief_title>f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea</brief_title>
  <official_title>The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator compared the sedative effects of propofol alone and ketamine added to&#xD;
      propofol in drug induced sleep endoscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural&#xD;
      sedation.&#xD;
&#xD;
      The investigator compared the effect of propofol and propofol ketamine in patients undergoing&#xD;
      drug induced sleep endoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)</measure>
    <time_frame>the duration of the procedure under sedation is usually about 20 minutes to complete the procedure</time_frame>
    <description>Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time until suﬃcient sedation to start endoscopy</measure>
    <time_frame>It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy</time_frame>
    <description>time to start endoscopy is deﬁned as the duration between start of the studied drugs until MOAA/S Modified observer assessment scale of alertness sedaion score 1 was obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total propofol and ketamine dose(mg)/patient needed/patient was calculated</measure>
    <time_frame>the procedure</time_frame>
    <description>The total propofol and ketamine(mg) /patient dose needed/patient was calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction</measure>
    <time_frame>the procedure</time_frame>
    <description>Once the DISE began, the airway interventions were important as outcomes, because these interrupted the clinical study of the DISE. Furthermore, laryngospasm was deﬁned by the requirement for positive pressure ventilation of &gt;20 cmH2O or administration of succinylcholine or propofol or any .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reﬂex, apnea or aspiration) were recorded during the procedure</measure>
    <time_frame>the procedure</time_frame>
    <description>Bradycardia was diagnosed if heart rate dropped below 60beats/min and atropine 0.01mg/kg was given if HR decreased below 50beats/min. Hypotension was diagnosed if mean arterial blood pressure (MAP) decreased by more than 30% from baseline or below 60mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time till Recovery</measure>
    <time_frame>an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4</time_frame>
    <description>Time between stop of the study drugs until Modified observer's assessment of alertness sedation MOAA/S score of 4 was calculated and patient is shifted to recovery room( MOAA/S score btween 0-6 where 1 patient is ready for endoscopic airway evaluation and 1 patient is ready for discharge to recovery room ) Time till (MOAA/S) score 4 was calculated .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients and surgeon satisfaction</measure>
    <time_frame>about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied</time_frame>
    <description>Both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room</measure>
    <time_frame>Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room</time_frame>
    <description>Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>propofol (P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive only propofol intravenous for sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol ketamine (pk)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive ketamine in addition to propofol intravenous for sedation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine + propofol</intervention_name>
    <description>effect of adding ketamine to propofol for patients undergoing DISE surgery</description>
    <arm_group_label>propofol ketamine (pk)</arm_group_label>
    <other_name>ketamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>effect of IV propofol alone for patients undergoing DISE surgery</description>
    <arm_group_label>propofol (P)</arm_group_label>
    <other_name>diprivan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age &gt; 18 years old.&#xD;
&#xD;
          -  American society of anesthesiologists (ASA) physical status I or II. I / II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  American society of anesthesiologists (ASA) physical status &gt; III&#xD;
&#xD;
          -  known or suspected allergy to the studied drugs or its components, allergy to eggs or&#xD;
             soy beans&#xD;
&#xD;
          -  morbid obesity&#xD;
&#xD;
          -  patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled&#xD;
             asthma, congestive e heart failure ,seizures ,or cerebrovascular disease&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heba M EL-Asser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heba M EL-Asser, MD</last_name>
    <phone>01062393152</phone>
    <email>aseelaswad1@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hala A Mohamed, MD</last_name>
    <phone>01000089532</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>Sarkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heba M ELasser, MD</last_name>
      <phone>01062393152</phone>
      <email>aseelaswad1@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cho JS, Soh S, Kim EJ, Cho HJ, Shin S, Kim HJ, Koo BN. Comparison of three sedation regimens for drug-induced sleep endoscopy. Sleep Breath. 2015 May;19(2):711-7. doi: 10.1007/s11325-015-1127-9. Epub 2015 Feb 3.</citation>
    <PMID>25643766</PMID>
  </reference>
  <reference>
    <citation>De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.</citation>
    <PMID>20811901</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>December 25, 2021</last_update_submitted>
  <last_update_submitted_qc>December 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Heba Mohamed EL -Asser,MD</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</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/NCT04452383
org study id: Sedation in DISE
nct id: NCT04452383
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigator compared the sedative effects of propofol alone and ketamine added to
      propofol in drug induced sleep endoscopy
Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural
      sedation.

      The investigator compared the effect of propofol and propofol ketamine in patients undergoing
      drug induced sleep endoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
measure: Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
time frame: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure
description: Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
measure: time until suﬃcient sedation to start endoscopy
time frame: It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
description: time to start endoscopy is deﬁned as the duration between start of the studied drugs until MOAA/S Modified observer assessment scale of alertness sedaion score 1 was obtained.
measure: The total propofol and ketamine dose(mg)/patient needed/patient was calculated
time frame: the procedure
description: The total propofol and ketamine(mg) /patient dose needed/patient was calculated
measure: any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction
time frame: the procedure
description: Once the DISE began, the airway interventions were important as outcomes, because these interrupted the clinical study of the DISE. Furthermore, laryngospasm was deﬁned by the requirement for positive pressure ventilation of >20 cmH2O or administration of succinylcholine or propofol or any .
measure: Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reﬂex, apnea or aspiration) were recorded during the procedure
time frame: the procedure
description: Bradycardia was diagnosed if heart rate dropped below 60beats/min and atropine 0.01mg/kg was given if HR decreased below 50beats/min. Hypotension was diagnosed if mean arterial blood pressure (MAP) decreased by more than 30% from baseline or below 60mmHg
measure: Time till Recovery
time frame: an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
description: Time between stop of the study drugs until Modified observer's assessment of alertness sedation MOAA/S score of 4 was calculated and patient is shifted to recovery room( MOAA/S score btween 0-6 where 1 patient is ready for endoscopic airway evaluation and 1 patient is ready for discharge to recovery room ) Time till (MOAA/S) score 4 was calculated .
measure: patients and surgeon satisfaction
time frame: about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied
description: Both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied
measure: Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room
time frame: Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room
description: Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room
arm group label: propofol (P)
arm group type: Active Comparator
description: patients will receive only propofol intravenous for sedation
arm group label: propofol ketamine (pk)
arm group type: Active Comparator
description: patients will receive ketamine in addition to propofol intravenous for sedation
intervention type: Drug
intervention name: Ketamine + propofol
description: effect of adding ketamine to propofol for patients undergoing DISE surgery
arm group label: propofol ketamine (pk)
other name: ketamine
intervention type: Drug
intervention name: propofol
description: effect of IV propofol alone for patients undergoing DISE surgery
arm group label: propofol (P)
other name: diprivan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heba M EL-Asser, MD
role: Principal Investigator
affiliation: Zagazig University
last name: Heba M EL-Asser, MD
phone: 01062393152
email: aseelaswad1@yahoo.com
last name: Hala A Mohamed, MD
phone: 01000089532
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Cho JS, Soh S, Kim EJ, Cho HJ, Shin S, Kim HJ, Koo BN. Comparison of three sedation regimens for drug-induced sleep endoscopy. Sleep Breath. 2015 May;19(2):711-7. doi: 10.1007/s11325-015-1127-9. Epub 2015 Feb 3.
PMID: 25643766
citation: De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.
PMID: 20811901
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Heba Mohamed EL -Asser,MD
investigator title: principal investigator
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Ketamine
mesh term: Propofol
sharing ipd: No