Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

Phase 4

Completed

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Drug: Propofol 10 MG/ML Injection; Drug: Sevoflurane Inhalation Liquid

• Registration Number: NCT05935930
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-07
• Status Verified: 2024-01
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P (n=22)	Propofol 10 MG/ML Injection	Propofol group
Group S (n=22)	Sevoflurane Inhalation Liquid	Sevoflurane group

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt