## Protocol Section
### Identification Module
**NCT ID:** NCT06423846

**Brief Title:** 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

#### Organization Study ID Info
**ID:** RC-3-4-2024
#### Organization
**Class:** OTHER
**Full Name:** Benha University
### Status Module
#### Completion Date
**Date:** 2024-05-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-06

**Type:** ACTUAL

#### Start Date
**Date:** 2024-01-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Benha University

#### Responsible Party

**Investigator Affiliation:** Benha University

**Investigator Full Name:** Ramy Mousa

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Laparoscopic Sleeve Gastrectomy

**Keywords:**

- Total Intravenous Anesthesia

- Inhalation Anesthesia

- Laparoscopic Sleeve Gastrectomy

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in the TIVA group had anesthesia induced with propofol 2 mg/kg , fentanyl 1 ug/kg and maintained with propofol.

**Intervention Names:**

- Drug: Total intravenous anesthesia group

**Label:** total intravenous anesthesia group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 Names:**

- Drug: sevoflurane group

**Label:** sevoflurane group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- total intravenous anesthesia group

**Description:** 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

**Name:** Total intravenous anesthesia group

**Other Names:**

- TIVA group

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- sevoflurane group

**Description:** 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.

**Name:** sevoflurane group

**Other Names:**

- SEVO group

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Pain was assessed by using the visual analogue scale (VAS) score for pain (0-no pain, 10-worst imaginable pain)

**Measure:** visual analogue scale

**Time Frame:** visual analogue scale was measured at day one and day two postoperatively

#### Secondary Outcomes

**Description:** 5-point Likert scale, (1=extremely dissatisfied; 5=extremely satisfied)

**Measure:** Patient satisfaction

**Time Frame:** 24 hours postoperatively

### Eligibility Module

**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

**Maximum Age:** 70 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Banha

**Country:** Egypt

**Facility:** Benha University

**Zip:** 13511

#### Overall Officials

**Official 1:**

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

**Name:** Ramy Saleh, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 34265444

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Inhalation

- ID: M8375

- Name: Fatty Liver

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5868

- Name: Visceral Steatosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

### Intervention Browse Module - Ancestors

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

- ID: D000018685

- Term: Anesthetics, Inhalation

- ID: D000018681

- Term: Anesthetics, General

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M22662

- Name: Dexmedetomidine

- Relevance: LOW

- As Found: Unknown

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M1673

- Name: Sevoflurane

- Relevance: HIGH

- As Found: Less

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20765

- Name: Anesthetics, Inhalation

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077149

- Term: Sevoflurane

### Misc Info Module

- Version Holder: 2024-05-31
