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

Sleep Apnea Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452383
• Other study ID #: Sedation in DISE
• Status: Recruiting
• Phase: Phase 4
• Start date: July 23, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2021
• Source: Zagazig University
• Contact: Heba M EL-Asser, MD
• Phone: 01062393152
• Email: aseelaswad1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Egypt	zagazig University	Zagazig	Sarkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time until su?cient sedation to start endoscopy	time to start endoscopy is de?ned 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
Secondary	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
Secondary	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 de?ned by the requirement for positive pressure ventilation of >20 cmH2O or administration of succinylcholine or propofol or any .	the procedure
Secondary	Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag re?ex, 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
Secondary	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
Secondary	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
Secondary	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