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NCT Number: NCT04452383

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

zagazig University

Zagazig, Sarkia, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine + propofol

Drug

effect of adding ketamine to propofol for patients undergoing DISE surgery

Other names: ketamine

Propofol

Drug

effect of IV propofol alone for patients undergoing DISE surgery

Other names: diprivan

Primary outcomes

  1. Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)

    Time frame: 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 outcomes

  1. time until sufficient sedation to start endoscopy

    Time frame: 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.

  2. The total propofol and ketamine dose(mg)/patient needed/patient was calculated

    Time frame: the procedure

    The total propofol and ketamine(mg) /patient dose needed/patient was calculated

  3. any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction

    Time frame: 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 .

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

    Time frame: 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

  5. Time till Recovery

    Time frame: 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 .

  6. patients and surgeon satisfaction

    Time frame: 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

  7. Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2020
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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