Isoflurane versus sevoflurane effects on oxidative stress during laparoscopic gallbladder removal
A Comparative Study Between the Impact of Isoflurane and Sevoflurane on Oxidative Stress in Patients Undergoing Laparoscopic Cholecystectomy
This trial will test whether isoflurane or sevoflurane causes different levels of oxidative stress in adults having elective laparoscopic gallbladder removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07152912 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective laparoscopic cholecystectomy will receive general anesthesia with either isoflurane or sevoflurane according to the protocol. Blood samples will be taken before and after anesthesia and surgery to measure markers of oxidative stress and inflammation. The study compares changes in those biomarkers between the two anesthetic exposures to see if one agent leads to less oxidant-related disruption. Participants meeting inclusion criteria and without the listed exclusions will be enrolled at a single center.
Who should consider this trial
Good fit: Adults aged 20–60 years with ASA physical status I–II who are scheduled for elective laparoscopic cholecystectomy and have no major chronic illnesses are the intended participants.
Not a fit: Patients with diabetes, chronic infection, major cardiac, hepatic, renal, endocrine, immune, mental or neurological disorders are excluded and the results may not apply to them.
Why it matters
Potential benefit: If one anesthetic produces less oxidative stress, clinicians could choose it to potentially reduce postoperative oxidative injury and inflammation.
How similar studies have performed: Previous comparisons of volatile anesthetics have shown mixed results, with some reports suggesting sevoflurane may be linked to lower oxidative stress but no clear consensus.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Eman A Ali, Master
- Email: eman.adel@med.asu.edu.eg
- Phone: 00201008005684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.