Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

Sponsor

Damanhour Teaching Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05935930

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
General Anesthetic Drug Adverse Reaction	Drug: Propofol 10 MG/ML Injection Drug: Sevoflurane Inhalation Liquid	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group P (n=22) Propofol group	Drug: Propofol 10 MG/ML Injection Propofol infusion
Active Comparator: Group S (n=22) Sevoflurane group	Drug: Sevoflurane Inhalation Liquid Sevoflurane inhalation

Arm

Intervention/Treatment

Active Comparator: Group P (n=22)

Propofol group

Drug: Propofol 10 MG/ML Injection

Propofol infusion

Active Comparator: Group S (n=22)

Sevoflurane group

Drug: Sevoflurane Inhalation Liquid

Sevoflurane inhalation

Outcome Measures

Primary Outcome Measures

Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD) [24 hours after the end of operation]
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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