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

• Sponsor: Theodor Bilharz Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT05027191
• Collaborator: Cairo University (Other)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 21.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); Drug: Desflurane; Drug: Sevoflurane

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Feb 15, 2018
• Actual Primary Completion Date: Nov 20, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Change in serum Neutrophil gelatinase-associated lipocalin (NGAL) [a change from baseline NGAL serum level at 6 hours]

   Renal Biomarker

Secondary Outcome Measures

1. Change in serum Arginase [Baseline, first hour, six hours, after 24 hours]

   Hepatic biomarker

2. Change in serum Cystatin-c [Baseline, first hour, six hours, after 24 hours]

   Hepatic biomarker

3. Change in urine Netrin-1 [Baseline, first hour, six hours, after 24 hours]

   Renal biomarker

4. Change in urine Kidney Injury Molecule [Baseline, first hour, six hours, after 24 hours]

   Renal biomarker

5. Change in urine Interleukin-18 [Baseline, first hour, six hours, after 24 hours]

   cytokines

6. Change in urine Alpha-Glutathione S-Transferase [Baseline, first hour, six hours, after 24 hours]

   Liver biomarker

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Theodor Bilharz Research Institute	Cairo		Egypt

Sponsors and Collaborators

• Theodor Bilharz Research Institute
• Cairo University

Investigators

• Principal Investigator: Khalda G Radwan, MD, Theodor Bilharz Rsearch Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: khalda Galal Moustafa, Principal Investigator, Theodor Bilharz Research Institute
• ClinicalTrials.gov Identifier: NCT05027191
• Other Study ID Numbers: 110-T
• First Posted: Aug 30, 2021
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Postoperative Complications; Sevoflurane; Desflurane

Study Results

No Results Posted as of Aug 30, 2021