Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function

May 16, 2024 updated by: Ramy Mousa, Benha University

Comparison of Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function in Patients With Non-Alcoholic Steatohepatitis Undergoing Laparoscopic Sleeve Gastrectomy: A Randomized Clinical Trial

The pandemic of obesity has become a serious issue of public health worldwide as the size of the obese population has almost tripled over the last four decades and continues to riseزThe epidemic of obesity has led to a significant increase in the prevalence of non-alcoholic fatty liver disease (NAFLD). NAFLD is currently the most common chronic liver disease, with an estimated global prevalence at 25-30%, rising up to 90% in morbidly obese patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anesthesia and surgery may deteriorate liver function in patients with elevated liver enzyme levels; therefore, in these patients, choosing anaesthetics with less hepatotoxicity may be important. Halothane, which is a typical inhalational anesthetic, is known for its liver and kidney toxicity. The latest anesthetic agents, including sevoflurane and desflurane, are associated with less hepatotoxicity, although rare cases of acute liver injury have been reported with these agentsزPropofol (2,6-diisopropylphenol) is an intravenous anesthetic. Its pharmacokinetic profile makes it very suitable for total intravenous anesthesia (TIVA) and this is a widely used technique in many centers. Its use results in a rapid onset and offset with fewer side effects including postoperative nausea and vomiting, making it particularly favorable in the ambulatory setting

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banha, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obese patients
  • had ASA I-III
  • diagnosed with non-alcoholic steatohepatitis (NASH) liver disease
  • undergoing laparoscopic sleeve gastrectomy

Exclusion Criteria:

  • cases wherein surgeries were performed using anesthetic methods that were not clearly identified as TIVA or INHA
  • heart surgery or cesarean section, and cases of neuromuscular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: total intravenous anesthesia group
Patients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol.
Drug: Total intravenous anesthesia group
Patients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol. 200 ug/kg/min, fentanyl 0.1ug/kg/min, dexmedetomidine 1 ug/kg/hour
Other Names:
  • TIVA group
Experimental: sevoflurane group
general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour.
Drug: sevoflurane group
For patients in the SEVO group, general anesthesia was induced with propofol 2 mg/kg, fentanyl 1 ug/kg and then maintained with sevoflurane in air and oxygen, dexmedetomidine 1 ug/kg/hour.
Other Names:
  • SEVO group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: visual analogue scale was measured at day one and day two postoperatively
Pain was assessed by using the visual analogue scale (VAS) score for pain (0-no pain, 10-worst imaginable pain)
visual analogue scale was measured at day one and day two postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 24 hours postoperatively
5-point Likert scale, (1=extremely dissatisfied; 5=extremely satisfied)
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Ramy Saleh, MD, Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Actual)

May 6, 2024

Study Completion (Actual)

May 12, 2024

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-3-4-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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