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

A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy

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).

Study Overview

• Status: Recruiting
• Conditions: Sevoflurane; Oxidative Stress; Laparoscopic Cholecystectomy; Isoflurane
• Intervention / Treatment: Drug: Isoflurane; Drug: Sevoflurane

Detailed Description

Oxidative stress is defined as "an imbalance between oxidants and antioxidants in favour of the oxidants, leading to a disruption of redox signalling and control and/or molecular damage.

Isoflurane, which has been utilized since the 1980s, has a particularly low metabolism rate and solubility, leading to reduced induction of anesthesia during surgery and shortened recovery time after surgery.

Sevoflurane began to be used a decade later and has a lower blood-gas partition coefficient than the other anesthetics, leading to rapid induction of anesthesia and fast awakening after anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman A Ali, Master; Phone Number: 00201008005684; Email: eman.adel@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Eman A Ali, Master; Phone Number: 00201008005684; Email: eman.adel@med.asu.edu.eg
    • Sub-Investigator: Ayman M Kamaly, MD
    • Sub-Investigator: Randa A Shoukry, MD
    • Sub-Investigator: Tarek S Shabana, MD
    • Sub-Investigator: Abdelrahman M Elsotouhy, MD
    • Sub-Investigator: Haitham K Sultan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Iso; Patients will receive general anesthesia and maintenance by isoflurane.	Drug: Isoflurane; Patients will receive general anesthesia and maintenance by isoflurane.
Experimental: Group Sev; Patients will receive general anesthesia and maintenance by sevoflurane.	Drug: Sevoflurane; Patients will receive general anesthesia and maintenance by sevoflurane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum level of superoxide dismutase	Serum level of superoxide dismutase (SOD) will be recorded.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum level of serum soluble programmed cell death-ligand 1	Serum level of serum soluble programmed cell death-ligand 1 (sPD-L1) will be recorded.	6 months postoperatively
Serum level of nuclear factor erythroid 2-related factor	Serum level of nuclear factor erythroid 2-related factor (Nrf2) will be recorded.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 26, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Sevoflurane; Isoflurane
• Other Study ID Numbers: FMASU MD185/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No