Clinical trial NCT06423846: Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Sleeve Gastrectomy
Keywords: Total Intravenous Anesthesia
Inhalation Anesthesia
Laparoscopic Sleeve Gastrectomy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale
timeFrame: visual analogue scale was measured at day one and day two postoperatively
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Benha University
Study officials:
affiliation: Anesthesia and surgical ICU department, Faculty of Medicine, Benha University, Egypt
name: Ramy Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.