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

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ClinicalTrials.gov Identifier: NCT04452383
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Heba Mohamed EL -Asser,MD, Zagazig University

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

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Drug: Ketamine + propofol Drug: propofol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: propofol (P)
patients will receive only propofol intravenous for sedation
Drug: propofol
effect of IV propofol alone for patients undergoing DISE surgery
Other Name: diprivan

Active Comparator: propofol ketamine (pk)
patients will receive ketamine in addition to propofol intravenous for sedation
Drug: Ketamine + propofol
effect of adding ketamine to propofol for patients undergoing DISE surgery
Other Name: ketamine




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452383


Contacts
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Contact: Heba M EL-Asser, MD 01062393152 aseelaswad1@yahoo.com
Contact: Hala A Mohamed, MD 01000089532

Locations
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Egypt
zagazig University Recruiting
Zagazig, Sarkia, Egypt, 44519
Contact: Heba M ELasser, MD    01062393152    aseelaswad1@yahoo.com   
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Heba M EL-Asser, MD Zagazig University
Publications:
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Responsible Party: Heba Mohamed EL -Asser,MD, principal investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT04452383    
Other Study ID Numbers: Sedation in DISE
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Ketamine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action