Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy

NCT07152912 | Recruiting

• 1 other identifier: FMASU MD185/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this work is to assess the impact of exposure to isoflurane or sevoflurane as an inhalation anesthetic on the oxidative stress and inflammatory conditions in patients undergoing elective moderate invasive surgery (laparoscopic cholecystectomy).

Conditions

Isoflurane; Sevoflurane; Oxidative Stress; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Serum level of superoxide dismutase

  Serum level of superoxide dismutase (SOD) will be recorded.

  6 months postoperatively

Secondary Outcomes (2)

• Serum level of serum soluble programmed cell death-ligand 1

  6 months postoperatively

• Serum level of nuclear factor erythroid 2-related factor

  6 months postoperatively

Study Arms (2)

Group Iso

EXPERIMENTAL

Patients will receive general anesthesia and maintenance by isoflurane.

Drug: Isoflurane

Group Sev

EXPERIMENTAL

Patients will receive general anesthesia and maintenance by sevoflurane.

Drug: Sevoflurane

Interventions

Isoflurane DRUG

Patients will receive general anesthesia and maintenance by isoflurane.

Group Iso

Sevoflurane DRUG

Patients will receive general anesthesia and maintenance by sevoflurane.

Group Sev

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 60 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) Physical Status I-II.
• Undergoing elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

• Refusal of participation in the study by patients.
• Diabetes (type I or II), endocrine system, and immune system diseases.
• Chronic infection and sepsis.
• Cardiac condition as classified bythe New York Heart Association (NYHA) \> class II.
• Hepatic disease: INR \> 1.5, and/or albumin \< 2.5 g/dL.
• Renal disease: glomerular filtration rate (GFR) \< 85 ml/min.
• Mental and neurological disorders.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Isoflurane; Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Eman A Ali, Master

CONTACT

00201008005684; eman.adel@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 4, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)