Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

General Anesthetic Drug Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935930
• Other study ID #: DTH: 22004
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Damanhour Teaching Hospital
• Contact: Ahmed M Shaat, MD
• Phone: 00201223482709
• Email: ahmedshaat99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• Propofol 10 MG/ML Injection
Propofol infusion
• Sevoflurane Inhalation Liquid
Sevoflurane inhalation

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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