Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

February 16, 2024 updated by: Damanhour Teaching Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Beheira
      • Damanhūr, El-Beheira, Egypt
        • Recruiting
        • Damanhour Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Time Frame: 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)
24 hours after the end of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour Teaching Hospital

Investigators

  • Principal Investigator: Ahmed M Shaat, MD, Damanhour Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTH: 22004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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