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

Evaluating the Effect of Desflurane Versus Sevoflurane With Recent Biomarkers of Renal and Hepatic Function in Laparoscopic Cholecystectomy Patients: A Prospective Randomized Double Blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Diagnostic test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); Drug: Sevoflurane; Drug: Desflurane

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

After informed written consents have been taken, this study will be conducted on 70 patients scheduled for laparoscopic cholecystectomy. The patients will be randomly allocated into two groups (a desflurane (D) group and a sevoflurane (S) group) using a sealed envelope technique for each group.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sevoflurane; This group will receive sevoflurane as the maintenance inhalational anesthetic.	Diagnostic test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.; Drug: Sevoflurane; Sevoflurane
Desflurane; This group will receive desflurane as the maintenance inhalational anesthetic.	Diagnostic test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.; Drug: Desflurane; Desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)	Renal Biomarker	a change from baseline NGAL serum level at 6 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute
• Collaborators: Cairo University
• Investigators: Principal Investigator: Khalda G Radwan, MD, Theodor Bilharz Rsearch Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Desflurane; Sevoflurane
• Other Study ID Numbers: 110-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes