Clinical trial NCT04452383: f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
timeFrame: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure
Secondary outcomes:
measure: time until suﬃcient sedation to start endoscopy
timeFrame: It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
measure: The total propofol and ketamine dose(mg)/patient needed/patient was calculated
timeFrame: the procedure
measure: any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction
timeFrame: the procedure
measure: Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reﬂex, apnea or aspiration) were recorded during the procedure
timeFrame: the procedure
measure: Time till Recovery
timeFrame: an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
measure: patients and surgeon satisfaction
timeFrame: 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
measure: Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room
timeFrame: Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: zagazig University
state: Sarkia
Study officials:
affiliation: Zagazig University
name: Heba M EL-Asser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.