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

NCT ID: NCT07152912

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2026-03-01

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.

Conditions

Isoflurane; Sevoflurane; Oxidative Stress; Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Iso

Patients will receive general anesthesia and maintenance by isoflurane.

Group Type: EXPERIMENTAL

Isoflurane

Intervention Type: DRUG

Patients will receive general anesthesia and maintenance by isoflurane.

Group Sev

Patients will receive general anesthesia and maintenance by sevoflurane.

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

Patients will receive general anesthesia and maintenance by sevoflurane.

Interventions

Isoflurane

Patients will receive general anesthesia and maintenance by isoflurane.

Intervention Type: DRUG

Sevoflurane

Patients will receive general anesthesia and maintenance by sevoflurane.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Eman adel ali abd moaty

Assistant Lecturer of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eman A Ali, Master

Role: CONTACT

eman.adel@med.asu.edu.eg

00201008005684

Facility Contacts

Eman A Ali, Master

Role: primary

eman.adel@med.asu.edu.eg

00201008005684

Other Identifiers

FMASU MD185/2024

Identifier Type: -

Identifier Source: org_study_id