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NCT Number: NCT07152912

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).

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

Location status: Recruiting

Location contact

Abdelrahman M Elsotouhy, MD

SUB_INVESTIGATOR

Ayman M Kamaly, MD

SUB_INVESTIGATOR

Eman A Ali, Master

CONTACT

[email protected]

00201008005684

Haitham K Sultan, MD

SUB_INVESTIGATOR

Randa A Shoukry, MD

SUB_INVESTIGATOR

Tarek S Shabana, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isoflurane

Drug

Patients will receive general anesthesia and maintenance by isoflurane.

Sevoflurane

Drug

Patients will receive general anesthesia and maintenance by sevoflurane.

Primary outcomes

  1. Serum level of superoxide dismutase

    Time frame: 6 months postoperatively

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

Secondary outcomes

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

    Time frame: 6 months postoperatively

    Serum level of serum soluble programmed cell death-ligand 1 (sPD-L1) will be recorded.

  2. Serum level of nuclear factor erythroid 2-related factor

    Time frame: 6 months postoperatively

    Serum level of nuclear factor erythroid 2-related factor (Nrf2) will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Eman A Ali, Master

CONTACT

[email protected]

00201008005684

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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