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

Overview

The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy

Full Title of Study: “The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 5, 2020

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.

Interventions

  • Drug: Ketamine + propofol
    • effect of adding ketamine to propofol for patients undergoing DISE surgery
  • Drug: propofol
    • effect of IV propofol alone for patients undergoing DISE surgery

Arms, Groups and Cohorts

  • Active Comparator: propofol (P)
    • patients will receive only propofol intravenous for sedation
  • Active Comparator: propofol ketamine (pk)
    • patients will receive ketamine in addition to propofol intravenous for sedation

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zagazig University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heba Mohamed EL -Asser,MD, principal investigator – Zagazig University
  • Overall Official(s)
    • Heba M EL-Asser, MD, Principal Investigator, Zagazig University
  • Overall Contact(s)
    • Heba M EL-Asser, MD, 01062393152, aseelaswad1@yahoo.com

References

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.

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.

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