Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function

NCT ID: NCT06423846

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-05-12

Brief Summary

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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

Detailed Description

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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

Conditions

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Laparoscopic Sleeve Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were randomized into two equal groups using a computer-generated list of random numbers sealed in an opaque envelope and were randomly allocated into two groups on a scale of 1:1.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Total intravenous anesthesia group

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

sevoflurane group

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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TIVA group SEVO group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ramy Mousa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramy Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt

Locations

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Benha University

Banhā, , Egypt

Site Status

Countries

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Egypt

References

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Ahmed OT, Gidener T, Mara KC, Larson JJ, Therneau TM, Allen AM. Natural History of Nonalcoholic Fatty Liver Disease With Normal Body Mass Index: A Population-Based Study. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1374-1381.e6. doi: 10.1016/j.cgh.2021.07.016. Epub 2021 Jul 13.

Reference Type BACKGROUND
PMID: 34265444 (View on PubMed)

Other Identifiers

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RC-3-4-2024

Identifier Type: -

Identifier Source: org_study_id

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