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CompletedNCT05935930Updated Feb 5, 2025

Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

A Phase 4 interventional study of Propofol 10 MG/ML Injection and Sevoflurane Inhalation Liquid in General Anesthetic Drug Adverse Reaction, sponsored by Damanhour Teaching Hospital. Completed at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Damanhour Teaching Hospital · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Dec 2021, registered Jun 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • General Anesthetic Drug Adverse Reaction

Keywords

  • Cognitive function
  • General anesthesia
  • Inflammatory response
  • Oxidative stress
  • Propofol
  • Sevoflurane
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's enrollment of 44 is below the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Damanhour Teaching Hospital is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Group P (n=22)

    Propofol group

    Drug: Propofol 10 MG/ML Injection

  • Active comparator
    Group S (n=22)

    Sevoflurane group

    Drug: Sevoflurane Inhalation Liquid

Interventions

  • DrugPropofol 10 MG/ML Injection

    Propofol infusion

  • DrugSevoflurane Inhalation Liquid

    Sevoflurane inhalation

06

What researchers measure

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)

    Time frame: 24 hours after the end of operation

07

Study locations

1 site
  • Damanhour Teaching Hospital
    Damanhūr, El-Beheira, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05935930
Lead sponsor
Damanhour Teaching Hospital
Responsible party
Sponsor
First posted
Jul 7, 2023
Start date
Dec 1, 2021
Primary completion
Dec 15, 2024
Completion
Dec 15, 2024
Last update
Feb 5, 2025

Study contacts

Ahmed M Shaat, MD
principal investigator · Damanhour Teaching Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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