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Recruiting NCT07152912

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

No phase Interventional Isoflurane Sevoflurane Oxidative Stress Laparoscopic Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isoflurane, Sevoflurane.
Who it may be relevant to
Registry conditions: Isoflurane, Sevoflurane, Oxidative Stress, Laparoscopic Cholecystectomy. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Isoflurane
    Patients will receive general anesthesia and maintenance by isoflurane.
  • Drug Sevoflurane
    Patients will receive general anesthesia and maintenance by sevoflurane.

Primary outcome measures

  • Serum level of superoxide dismutase [Time frame: 6 months postoperatively]
Secondary outcome measures (2)
  • Serum level of serum soluble programmed cell death-ligand 1 [Time frame: 6 months postoperatively]
  • Serum level of nuclear factor erythroid 2-related factor [Time frame: 6 months postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07152912 · FMASU MD185/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗