Effect of Desflurane Versus Sevoflurane With Recent Bio-markers on Renal and Hepatic Functions

Completed

• Conditions: Postoperative Complications
• Interventions: Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); Drug: Sevoflurane; Drug: Desflurane

• Registration Number: NCT05027191
• Lead Sponsor: Theodor Bilharz Research Institute

Brief Summary

Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Study First Submitted: 2019-09-11
• Primary Completion: 2019-11-20
• Study Completion: 2019-12-01
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-23
• Last Update Submitted: 2021-08-23
• Study First Posted: 2021-08-30
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. American Society of Anesthesiologists (ASA) Class: I&II.
2. Elective laparoscopic cholecystectomy.
3. Age: 25-55 years.
4. Gender: Both male and female.
5. Body Mass Index (BMI): 18.5-24.9 km2-(Normal weight).

Exclusion Criteria

1. Extremes of age.
2. Abnormal hepatic function by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values outside the normal range.
3. Abnormal renal function by blood urea nitrogen (BUN) and creatinine above the normal ranges.
4. Hypertension, unstable angina pectoris or myocardial infarction within the last six months.
5. Pregnancy and lactation.
6. Bronchial asthma.
7. Drug allergies.
8. Alcohol or drug addiction.
9. General anesthesia within the last three months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Neutrophil Gelatinase-Associated Lipocalin (NGAL)	This group will receive sevoflurane as the maintenance inhalational anesthetic.
Desflurane	Neutrophil Gelatinase-Associated Lipocalin (NGAL)	This group will receive desflurane as the maintenance inhalational anesthetic.
Sevoflurane	Sevoflurane	This group will receive sevoflurane as the maintenance inhalational anesthetic.
Desflurane	Desflurane	This group will receive desflurane as the maintenance inhalational anesthetic.

Primary Outcome Measures

Name	Time	Method
Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)	a change from baseline NGAL serum level at 6 hours	Renal Biomarker

Secondary Outcome Measures

Name	Time	Method
Change in serum Arginase	Baseline, first hour, six hours, after 24 hours	Hepatic biomarker
Change in serum Cystatin-c	Baseline, first hour, six hours, after 24 hours	Hepatic biomarker
Change in urine Interleukin-18	Baseline, first hour, six hours, after 24 hours	cytokines
Change in urine Netrin-1	Baseline, first hour, six hours, after 24 hours	Renal biomarker
Change in urine Kidney Injury Molecule	Baseline, first hour, six hours, after 24 hours	Renal biomarker
Change in urine Alpha-Glutathione S-Transferase	Baseline, first hour, six hours, after 24 hours	Liver biomarker

Trial Locations

Locations (1)

Theodor Bilharz Research Institute; 🇪🇬 Cairo, Egypt