Skip to content

VIMA vs TIVA and ONSD in Laparoscopic Cholecystectomy

Volatile Versus Total Intravenous Anesthesia and Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07786740
Enrollment
80
Registered
2026-08-26
Start date
2023-01-01
Completion date
2023-05-05
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Change, Optic Nerve Diameter

Keywords

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

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.

Detailed description

This prospective, single-center, randomized, open-label study compared total intravenous anesthesia (TIVA) with volatile induction and maintenance anesthesia (VIMA) in adult patients undergoing elective laparoscopic cholecystectomy. The primary objective was to evaluate whether the anesthetic technique influenced perioperative changes in optic nerve sheath diameter (ONSD), a noninvasive ultrasonographic surrogate marker of intracranial pressure. ONSD was measured from the right eye using a 12-MHz linear ultrasound probe at six predefined perioperative time points: before induction, after tracheal intubation, after pneumoperitoneum, after reverse Trendelenburg positioning, 30 minutes after intubation, and after desufflation. Six consecutive measurements were obtained at each time point and averaged. Pneumoperitoneum pressure was maintained at 12 mmHg, reverse Trendelenburg positioning was 15°-30°, and anesthetic depth was guided by Bispectral Index monitoring. Secondary assessments included intraoperative hemodynamic and respiratory variables, postoperative pain, nausea, vomiting, headache, diplopia, recovery time, and anesthetic drug cost. The final analysis was performed on the evaluable per-protocol population.

Interventions

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.

DRUGRemifentanil

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

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.

Sponsors

Bagcilar Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Optic Nerve Sheath Diameter During the Perioperative PeriodFrom before induction of anesthesia to 5 minutes after desufflationOptic 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.

Secondary

MeasureTime frameDescription
Systolic Arterial PressureFrom before induction of anesthesia to 5 minutes after desufflationSystolic arterial pressure were recorded and compared between the TIVA and VIMA groups.
Change in Peripheral Oxygen SaturationFrom before induction of anesthesia to 5 minutes after desufflationPeripheral oxygen saturation (SpO₂) was recorded and compared between groups
Change in Bispectral IndexFrom before induction of anesthesia to 5 minutes after desufflationBispectral Index (BIS) values were recorded to assess anesthetic depth and compared between groups
Anesthetic Drug CostFrom induction of anesthesia to completion of anesthesiaTotal intraoperative consumption of propofol and remifentanil in the TIVA group and sevoflurane in the VIMA group was recorded, and anesthetic drug cost was calculated in Turkish Lira using the 2023 hospital acquisition price list.
Diastolic Arterial PressureFrom before induction of anesthesia to 5 minutes after desufflationDiastolic arterial pressure was recorded in millimeters of mercury (mmHg) at T0, T1, T2, T3, T4, and T5.
Mean Arterial PressureFrom before induction of anesthesia to 5 minutes after desufflationMean arterial pressure was recorded in millimeters of mercury (mmHg) at T0, T1, T2, T3, T4, and T5.
Heart RateFrom before induction of anesthesia to 5 minutes after desufflationHeart rate was recorded in beats per minute at T0, T1, T2, T3, T4, and T5.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026