NCT05027191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

September 11, 2019

Last Update Submit

August 23, 2021

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)

    Renal Biomarker

    a change from baseline NGAL serum level at 6 hours

Secondary Outcomes (6)

  • Change in serum Arginase

    Baseline, first hour, six hours, after 24 hours

  • Change in serum Cystatin-c

    Baseline, first hour, six hours, after 24 hours

  • Change in urine Netrin-1

    Baseline, first hour, six hours, after 24 hours

  • Change in urine Kidney Injury Molecule

    Baseline, first hour, six hours, after 24 hours

  • Change in urine Interleukin-18

    Baseline, first hour, six hours, after 24 hours

  • +1 more secondary outcomes

Study Arms (2)

Sevoflurane

This group will receive sevoflurane as the maintenance inhalational anesthetic.

Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL)Drug: Sevoflurane

Desflurane

This group will receive desflurane as the maintenance inhalational anesthetic.

Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL)Drug: Desflurane

Interventions

Neutrophil Gelatinase-Associated Lipocalin (NGAL)DIAGNOSTIC_TEST

The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.

DesfluraneSevoflurane
DesfluraneDRUG

Desflurane

Desflurane
SevofluraneDRUG

Sevoflurane

Sevoflurane

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Theodor Bilharz Research Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

DesfluraneSevoflurane

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Khalda G Radwan, MD

    Theodor Bilharz Rsearch Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

August 30, 2021

Study Start

February 15, 2018

Primary Completion

November 20, 2019

Study Completion

December 1, 2019

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

EG(1)