Back to resultsf Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea Syndromes
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine + propofol
propofol
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Apnea Syndromes
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
Sites / Locations
- zagazig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
propofol (P)
propofol ketamine (pk)
Arm Description
patients will receive only propofol intravenous for sedation
patients will receive ketamine in addition to propofol intravenous for sedation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
time until sufficient sedation 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.
The total propofol and ketamine dose(mg)/patient needed/patient was calculated
The total propofol and ketamine(mg) /patient dose needed/patient was calculated
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 defined by the requirement for positive pressure ventilation of >20 cmH2O or administration of succinylcholine or propofol or any .
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, 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
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 .
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04452383
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propofol (P)
Arm Type
Active Comparator
Arm Description
patients will receive only propofol intravenous for sedation
Arm Title
propofol ketamine (pk)
Arm Type
Active Comparator
Arm Description
patients will receive ketamine in addition to propofol intravenous for sedation
Intervention Type
Drug
Intervention Name(s)
Ketamine + propofol
Other Intervention Name(s)
ketamine
Intervention Description
effect of adding ketamine to propofol for patients undergoing DISE surgery
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
diprivan
Intervention Description
effect of IV propofol alone for patients undergoing DISE surgery
Primary Outcome Measure Information:
Title
Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)
Description
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
Secondary Outcome Measure Information:
Title
time until sufficient sedation to start endoscopy
Description
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.
Time Frame
It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy
Title
The total propofol and ketamine dose(mg)/patient needed/patient was calculated
Description
The total propofol and ketamine(mg) /patient dose needed/patient was calculated
Time Frame
the procedure
Title
any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction
Description
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 .
Time Frame
the procedure
Title
Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reflex, apnea or aspiration) were recorded during the procedure
Description
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
Time Frame
the procedure
Title
Time till Recovery
Description
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 .
Time Frame
an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4
Title
patients and surgeon satisfaction
Description
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
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
Title
Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room
Description
Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba M EL-Asser, MD
Phone
01062393152
Email
aseelaswad1@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hala A Mohamed, MD
Phone
01000089532
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M EL-Asser, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
zagazig University
City
Zagazig
State/Province
Sarkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba M ELasser, MD
Phone
01062393152
Email
aseelaswad1@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25643766
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.
Results Reference
background
PubMed Identifier
20811901
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.
Results Reference
background
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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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