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

A

Ain Shams University

Status

Enrolling

Conditions

Laparoscopic Cholecystectomy
Oxidative Stress
Sevoflurane
Isoflurane

Treatments

Drug: Sevoflurane
Drug: Isoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT07152912
FMASU MD185/2024

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Group Iso
Experimental group
Description:
Patients will receive general anesthesia and maintenance by isoflurane.
Treatment:
Drug: Isoflurane
Group Sev
Experimental group
Description:
Patients will receive general anesthesia and maintenance by sevoflurane.
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Central trial contact

Eman A Ali, Master

Data sourced from clinicaltrials.gov

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