Postoperative Effects of Propofol Versus Sevoflurane Anes... | NCT05935930

Studies
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

NCT05935930

Sponsor

Damanhour Teaching Hospital

Status

Completed

Last Update Posted

Feb 5, 2025Actual

Enrollment

44Actual

Phase

Phase 4

Conditions

General Anesthetic Drug Adverse Reaction

Interventions

Propofol 10 MG/ML Injection
Sevoflurane Inhalation Liquid

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Dec 15, 2024Actual

Completion Date

Dec 15, 2024Actual

First Submitted Date

Jun 27, 2023

First Submission Date that Met QC Criteria

Jul 5, 2023

First Posted Date

Jul 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2025

Last Update Posted Date

Feb 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group P (n=22)	Active Comparator	Propofol group	Drug: Propofol 10 MG/ML Injection
Group S (n=22)	Active Comparator	Sevoflurane group	Drug: Sevoflurane Inhalation Liquid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol 10 MG/ML Injection	Drug	Propofol infusion	Group P (n=22)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed M Shaat, MD	Damanhour Teaching Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Damanhour Teaching Hospital		Damanhūr	El-Beheira		Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D007267	Injections

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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