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

NCT04452383 | Unknown Phase 4

• 1 other identifier: Sedation in DISE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• The total propofol and ketamine dose(mg)/patient 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

  the procedure

• Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure

  the procedure

• Time till Recovery

  an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4

Study Arms (2)

propofol (P)

ACTIVE COMPARATOR

patients will receive only propofol intravenous for sedation

Drug: propofol

propofol ketamine (pk)

ACTIVE COMPARATOR

patients will receive ketamine in addition to propofol intravenous for sedation

Drug: Ketamine + propofol

Interventions

Ketamine + propofol DRUG

effect of adding ketamine to propofol for patients undergoing DISE surgery

Also known as: ketamine

propofol ketamine (pk)

propofol DRUG

effect of IV propofol alone for patients undergoing DISE surgery

Also known as: diprivan

propofol (P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old.
• American society of anesthesiologists (ASA) physical status I or II. I / II

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

zagazig University

Zagazig, Sarkia, 44519, Egypt

RECRUITING

Related 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.

  PMID: 25643766 BACKGROUND

• 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.

  PMID: 20811901 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Ketamine; Propofol

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Heba M EL-Asser, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba M EL-Asser, MD

CONTACT

01062393152; aseelaswad1@yahoo.com

Hala A Mohamed, MD

CONTACT

01000089532

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 30, 2020
• Study Start: July 23, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)