VIMA vs TIVA and ONSD in Laparoscopic Cholecystectomy

NCT07786740 | Completed Phase 4

• 1 other identifier: 2022/378
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two commonly used general anesthesia techniques in adults undergoing elective laparoscopic gallbladder surgery. One group received total intravenous anesthesia (TIVA) with propofol, while the other group received volatile induction and maintenance anesthesia (VIMA) with sevoflurane. The main purpose of the study was to compare changes in optic nerve sheath diameter, measured noninvasively by ultrasound, because this measurement can reflect changes in pressure inside the skull. Measurements were taken at several time points before, during, and after surgery. The study also compared blood pressure, heart rate, oxygen levels, depth of anesthesia, breathing-related measurements, postoperative pain, nausea, vomiting, headache, recovery time, and anesthetic drug cost between the two groups. Adult patients aged 18 to 80 years with ASA physical status I-II who were scheduled for elective laparoscopic cholecystectomy were included. The study was conducted at Istanbul Bağcılar Training and Research Hospital.

Conditions

Intracranial Pressure Change; Optic Nerve Diameter

Keywords

optic nerve sheath diameter; total intravenous anesthesia; sevoflurane; propofol; laparoscopic cholecystectomy; pneumoperitoneum; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Change in Optic Nerve Sheath Diameter During the Perioperative Period

  Optic nerve sheath diameter (ONSD) was measured ultrasonographically in the right eye using a 12-MHz linear probe, 3 mm posterior to the point at which the optic nerve enters the globe. Six consecutive measurements were obtained at each time point and averaged. The perioperative ONSD profile was compared between the TIVA and VIMA groups.

  From before induction of anesthesia to 5 minutes after desufflation

Secondary Outcomes (7)

• Systolic Arterial Pressure

  From before induction of anesthesia to 5 minutes after desufflation

• Change in Peripheral Oxygen Saturation

  From before induction of anesthesia to 5 minutes after desufflation

• Change in Bispectral Index

  From before induction of anesthesia to 5 minutes after desufflation

• Anesthetic Drug Cost

  From induction of anesthesia to completion of anesthesia

• Diastolic Arterial Pressure

  From before induction of anesthesia to 5 minutes after desufflation

Study Arms (2)

Total Intravenous Anesthesia (TIVA)

EXPERIMENTAL

Anesthesia was induced with intravenous propofol 2-2.5 mg/kg and fentanyl 2 µg/kg, with rocuronium 0.6 mg/kg for neuromuscular blockade. Anesthesia was maintained with propofol infusion (75-250 µg/kg/min) and remifentanil infusion (0.1 µg/kg/min), titrated to maintain a Bispectral Index of 40-60.

Drug: Propofol (Astra-Zeneca); Drug: Remifentanil

Volatile Induction and Maintenance Anesthesia (VIMA)

ACTIVE COMPARATOR

Anesthesia was induced with 8% sevoflurane in a 50% oxygen/50% air mixture at a fresh gas flow of 6 L/min. Fentanyl 2 µg/kg and rocuronium 0.6 mg/kg were administered, followed by endotracheal intubation. Anesthesia was maintained with sevoflurane 2.5-3.3%, titrated to maintain a Bispectral Index of 40-60.

Drug: Sevofluorane

Interventions

Propofol (Astra-Zeneca) DRUG

Propofol was administered intravenously at 2-2.5 mg/kg for induction of anesthesia and was continued as an infusion at 75-250 µg/kg/min for maintenance, titrated to maintain a Bispectral Index of 40-60.

Total Intravenous Anesthesia (TIVA)

Remifentanil DRUG

Remifentanil was administered as a continuous intravenous infusion at 0.1 µg/kg/min during maintenance of anesthesia in the TIVA group.

Total Intravenous Anesthesia (TIVA)

Sevofluorane DRUG

Sevoflurane was administered at 8% in a 50% oxygen/50% air mixture with a fresh gas flow of 6 L/min for inhalational induction. Anesthesia was maintained with sevoflurane at 2.5-3.3%, titrated to maintain a Bispectral Index of 40-60.

Volatile Induction and Maintenance Anesthesia (VIMA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective laparoscopic cholecystectomy
• Provided written informed consent to participate

You may not qualify if:

• Refusal to participate
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• History of malignancy
• Severe cardiovascular disease, including congestive heart failure or myocardial infarction
• Severe cerebrovascular disease, including previous stroke
• Hepatic dysfunction
• Renal dysfunction
• Pregnancy or lactation
• Intracranial space-occupying lesion or any condition predisposing to increased intracranial pressure
• Known optic nerve pathology

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Isntabul Bagcilar Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Model Details: Participants were assigned to one of two parallel anesthesia groups: total intravenous anesthesia (TIVA) or volatile induction and maintenance anesthesia (VIMA).

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 5, 2023
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)