Isntabul Bagcilar Research and Training Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT07786740
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Peripheral oxygen saturation (SpO₂) was recorded and compared between groups
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
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.
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.
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.
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.
Bagcilar Training and Research Hospital
Other Gov
Volatile Versus Total Intravenous Anesthesia and Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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