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

Not Applicable

Recruiting

• Conditions: Isoflurane; Laparoscopic Cholecystectomy; Sevoflurane; Oxidative Stress
• Interventions: Drug: Isoflurane; Drug: Sevoflurane

• Registration Number: NCT07152912
• Lead Sponsor: Ain Shams University

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).

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 Timeline

• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Status Verified: 2025-09
• Study First Posted: 2025-09-03
• Study Start: 2025-09-04
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Iso	Isoflurane	Patients will receive general anesthesia and maintenance by isoflurane.
Group Sev	Sevoflurane	Patients will receive general anesthesia and maintenance by sevoflurane.

Primary Outcome Measures

Name	Time	Method
Serum level of superoxide dismutase	6 months postoperatively	Serum level of superoxide dismutase (SOD) will be recorded.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt