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Clinical Trials/NCT05935930
NCT05935930
Completed
Phase 4

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

Damanhour Teaching Hospital1 site in 1 country44 target enrollmentDecember 1, 2021

Overview

Phase
Phase 4
Intervention
Propofol 10 MG/ML Injection
Conditions
General Anesthetic Drug Adverse Reaction
Sponsor
Damanhour Teaching Hospital
Enrollment
44
Locations
1
Primary Endpoint
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
December 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Damanhour Teaching Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Group P (n=22)

Propofol group

Intervention: Propofol 10 MG/ML Injection

Group S (n=22)

Sevoflurane group

Intervention: Sevoflurane Inhalation Liquid

Outcomes

Primary Outcomes

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)

Study Sites (1)

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