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f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT04452383
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Heba Mohamed EL -Asser,MD, Zagazig University

Tracking Information
First Submitted Date  ICMJE June 21, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date December 28, 2021
Actual Study Start Date  ICMJE July 23, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
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 ]
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
  • 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 ]
    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.
  • The total propofol and ketamine dose(mg)/patient needed/patient was calculated [ Time Frame: the procedure ]
    The total propofol and ketamine(mg) /patient dose needed/patient was calculated
  • 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 ]
    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 .
  • Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure [ Time Frame: the procedure ]
    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
  • 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 ]
    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 .
  • 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 ]
    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 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 ]
    Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea
Official Title  ICMJE The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study
Brief Summary The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Primary Purpose: Supportive Care
Condition  ICMJE Sleep Apnea Syndromes
Intervention  ICMJE
  • Drug: Ketamine + propofol
    effect of adding ketamine to propofol for patients undergoing DISE surgery
    Other Name: ketamine
  • Drug: propofol
    effect of IV propofol alone for patients undergoing DISE surgery
    Other Name: diprivan
Study Arms  ICMJE
  • Active Comparator: propofol (P)
    patients will receive only propofol intravenous for sedation
    Intervention: Drug: propofol
  • Active Comparator: propofol ketamine (pk)
    patients will receive ketamine in addition to propofol intravenous for sedation
    Intervention: Drug: Ketamine + propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age > 18 years old.
  • American society of anesthesiologists (ASA) physical status I or II. I / II

Exclusion Criteria:

  • patient refusal
  • American society of anesthesiologists (ASA) physical status > III
  • known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans
  • morbid obesity
  • patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heba M EL-Asser, MD 01062393152 aseelaswad1@yahoo.com
Contact: Hala A Mohamed, MD 01000089532
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452383
Other Study ID Numbers  ICMJE Sedation in DISE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heba Mohamed EL -Asser,MD, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heba M EL-Asser, MD Zagazig University
PRS Account Zagazig University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP