Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
RC-3-4-2024
Description
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
Trial arms
Trial start
2024-01-26
Estimated PCD
2024-05-06
Trial end
2024-05-12
Status
Completed
Treatment
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
Arms:
total intravenous anesthesia group
Other names:
TIVA group
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.
Arms:
sevoflurane group
Other names:
SEVO group
Size
80
Primary endpoint
visual analogue scale
visual analogue scale was measured at day one and day two postoperatively
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2024-05-21

1 organization

2 products

1 indication

Organization
Benha University
Product
Total intravenous anesthesia
Indication
Sleeve Gastrectomy
Product
Sevoflurane