Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function

Laparoscopic Sleeve Gastrectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06423846
• Other study ID #: RC-3-4-2024
• Status: Completed
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: May 12, 2024

Study information

• Verified date: May 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 12, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy
• Respiratory Aspiration

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Benha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	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	Patient satisfaction	5-point Likert scale, (1=extremely dissatisfied; 5=extremely satisfied)	24 hours postoperatively