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

The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Drug: propofol; Drug: Ketamine + propofol

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heba M EL-Asser, MD; Phone Number: 01062393152; Email: aseelaswad1@yahoo.com
• Study Contact Backup: Name: Hala A Mohamed, MD; Phone Number: 01000089532

Study Locations

• Egypt
  • Sarkia
    • Zagazig, Sarkia, Egypt, 44519
      • Recruiting
      • Zagazig University
      • Contact: Heba M ELasser, MD; Phone Number: 01062393152; Email: aseelaswad1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol (P); patients will receive only propofol intravenous for sedation	Drug: propofol; effect of IV propofol alone for patients undergoing DISE surgery; Other Names: diprivan
Active Comparator: propofol ketamine (pk); patients will receive ketamine in addition to propofol intravenous for sedation	Drug: Ketamine + propofol; effect of adding ketamine to propofol for patients undergoing DISE surgery; Other Names: ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)	Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)	the duration of the procedure under sedation is usually about 20 minutes to complete the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until sufficient sedation 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.	It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
The total propofol and ketamine dose(mg)/patient needed/patient was calculated	The total propofol and ketamine(mg) /patient dose needed/patient was calculated	the procedure
any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction	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 .	the procedure
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during 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	the procedure
Time till Recovery	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 .	an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
patients and surgeon satisfaction	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	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 to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure 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	Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 25, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: Sedation in DISE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No