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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027191
• Other study ID #: 110-T
• Status: Completed
• Start date: February 15, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2021
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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
• Sevoflurane
Sevoflurane

Locations

Country	Name	City	State
Egypt	Theodor Bilharz Research Institute	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)	Renal Biomarker	a change from baseline NGAL serum level at 6 hours
Secondary	Change in serum Arginase	Hepatic biomarker	Baseline, first hour, six hours, after 24 hours
Secondary	Change in serum Cystatin-c	Hepatic biomarker	Baseline, first hour, six hours, after 24 hours
Secondary	Change in urine Netrin-1	Renal biomarker	Baseline, first hour, six hours, after 24 hours
Secondary	Change in urine Kidney Injury Molecule	Renal biomarker	Baseline, first hour, six hours, after 24 hours
Secondary	Change in urine Interleukin-18	cytokines	Baseline, first hour, six hours, after 24 hours
Secondary	Change in urine Alpha-Glutathione S-Transferase	Liver biomarker	Baseline, first hour, six hours, after 24 hours