Back to resultsPostoperative Effects of Propofol Versus Sevoflurane Anesthesia
Primary Purpose
General Anesthetic Drug Adverse Reaction
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Propofol 10 MG/ML Injection
Sevoflurane Inhalation Liquid
Sponsored by
About this trial
This is an interventional other trial for General Anesthetic Drug Adverse Reaction focused on measuring Cognitive function, General anesthesia, Inflammatory response, Oxidative stress, Propofol, Sevoflurane
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status ≤ II Age from 21 years Body Mass Index (BMI) 25-35 kg/m2 Exclusion Criteria: ASA physical status > II Age < 21 years Patients with Montreal Objective Cognitive Assessment (MoCA-B) score < 24 points Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia Patients on long-term use of sedatives or steroids, alcohol or drug abuse Allergy to any of the study drugs
Sites / Locations
- Damanhour Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group P (n=22)
Group S (n=22)
Arm Description
Propofol group
Sevoflurane group
Outcomes
Primary Outcome Measures
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)
Secondary Outcome Measures
Full Information
NCT ID
NCT05935930
First Posted
June 27, 2023
Last Updated
September 25, 2023
Sponsor
Damanhour Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05935930
Brief Title
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia
Official Title
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital
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
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.
Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.
Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthetic Drug Adverse Reaction
Keywords
Cognitive function, General anesthesia, Inflammatory response, Oxidative stress, Propofol, Sevoflurane
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group P (n=22)
Arm Type
Active Comparator
Arm Description
Propofol group
Arm Title
Group S (n=22)
Arm Type
Active Comparator
Arm Description
Sevoflurane group
Intervention Type
Drug
Intervention Name(s)
Propofol 10 MG/ML Injection
Intervention Description
Propofol infusion
Intervention Type
Drug
Intervention Name(s)
Sevoflurane Inhalation Liquid
Intervention Description
Sevoflurane inhalation
Primary Outcome Measure Information:
Title
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Description
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)
Time Frame
24 hours after the end of operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status ≤ II
Age from 21 years
Body Mass Index (BMI) 25-35 kg/m2
Exclusion Criteria:
ASA physical status > II
Age < 21 years
Patients with Montreal Objective Cognitive Assessment (MoCA-B) score < 24 points
Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
Patients on long-term use of sedatives or steroids, alcohol or drug abuse
Allergy to any of the study drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Phone
00201223482709
Email
ahmedshaat99@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia
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