Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

NCT ID: NCT05935930

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthetic Drug Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group P (n=22)

Propofol group

Group Type ACTIVE_COMPARATOR

Propofol 10 MG/ML Injection

Intervention Type DRUG

Propofol infusion

Group S (n=22)

Sevoflurane group

Group Type ACTIVE_COMPARATOR

Sevoflurane Inhalation Liquid

Intervention Type DRUG

Sevoflurane inhalation

Interventions

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Propofol 10 MG/ML Injection

Propofol infusion

Intervention Type DRUG

Sevoflurane Inhalation Liquid

Sevoflurane inhalation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

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Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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DTH: 22004

Identifier Type: -

Identifier Source: org_study_id

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