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

Phase 4

• Conditions: Sleep Apnea Syndromes
• Interventions: Drug: Ketamine + propofol; Drug: propofol

• Registration Number: NCT04452383
• Lead Sponsor: Zagazig University

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 Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-06-30
• Study Start: 2020-07-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-25
• Last Update Posted: 2021-12-28
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol ketamine (pk)	Ketamine + propofol	patients will receive ketamine in addition to propofol intravenous for sedation
propofol (P)	propofol	patients will receive only propofol intravenous for sedation

Primary Outcome Measures

Name	Time	Method
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	Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)

Secondary Outcome Measures

Name	Time	Method
any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction	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 .
time until sufficient sedation to start endoscopy	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	the procedure	The total propofol and ketamine(mg) /patient dose needed/patient was calculated
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure	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	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	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	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

Trial Locations

Locations (1)

zagazig University; 🇪🇬 Zagazig, Sarkia, Egypt