Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

NCT05935930 | Completed Phase 4

• 1 other identifier: DTH: 22004
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

Cognitive function; General anesthesia; Inflammatory response; Oxidative stress; Propofol; Sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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)

  24 hours after the end of operation

Study Arms (2)

Group P (n=22)

ACTIVE COMPARATOR

Propofol group

Drug: Propofol 10 MG/ML Injection

Group S (n=22)

ACTIVE COMPARATOR

Sevoflurane group

Drug: Sevoflurane Inhalation Liquid

Interventions

Propofol 10 MG/ML Injection DRUG

Propofol infusion

Group P (n=22)

Sevoflurane Inhalation Liquid DRUG

Sevoflurane inhalation

Group S (n=22)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status ≤ II
• Age from 21 years
• Body Mass Index (BMI) 25-35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour Teaching Hospital: lead

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Interventions

Propofol; Injections

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ahmed M Shaat, MD

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: December 1, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: February 5, 2025

Record last verified: 2024-01

Locations

EG (1)