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Completed

NCT Number: NCT07786740

VIMA vs TIVA and ONSD in Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Isntabul Bagcilar Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Remifentanil

Drug

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

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.

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter During the Perioperative Period

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    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.

Secondary outcomes

  1. Systolic Arterial Pressure

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Systolic arterial pressure were recorded and compared between the TIVA and VIMA groups.

  2. Change in Peripheral Oxygen Saturation

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Peripheral oxygen saturation (SpO₂) was recorded and compared between groups

  3. Change in Bispectral Index

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Bispectral Index (BIS) values were recorded to assess anesthetic depth and compared between groups

  4. Anesthetic Drug Cost

    Time frame: From induction of anesthesia to completion of anesthesia

    Total 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.

  5. Diastolic Arterial Pressure

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Diastolic arterial pressure was recorded in millimeters of mercury (mmHg) at T0, T1, T2, T3, T4, and T5.

  6. Mean Arterial Pressure

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Mean arterial pressure was recorded in millimeters of mercury (mmHg) at T0, T1, T2, T3, T4, and T5.

  7. Heart Rate

    Time frame: From before induction of anesthesia to 5 minutes after desufflation

    Heart rate was recorded in beats per minute at T0, T1, T2, T3, T4, and T5.

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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