Total Intravenous Anesthesia Versus Inhalation Anesthesia on Postoperative Liver Function

NCT06423846 | Completed

• 1 other identifier: RC-3-4-2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Laparoscopic Sleeve Gastrectomy

Keywords

Total Intravenous Anesthesia; Inhalation Anesthesia; Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  24 hours postoperatively

Study Arms (2)

total intravenous anesthesia group

EXPERIMENTAL

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

sevoflurane group

EXPERIMENTAL

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

Interventions

Total intravenous anesthesia group 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

Also known as: TIVA group

total intravenous anesthesia group

sevoflurane group 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.

Also known as: SEVO group

sevoflurane group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, 13511, Egypt

Location

Related 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.

  PMID: 34265444 BACKGROUND

Study Officials

• Ramy Saleh, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: January 26, 2024
• Primary Completion: May 6, 2024
• Study Completion: May 12, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)