A Phase 4 interventional study of Propofol (Astra-Zeneca) and Remifentanil in Intracranial Pressure Change and Optic Nerve Diameter, sponsored by Bagcilar Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Bagcilar Training and Research Hospital · Phase 4, Interventional, and Other
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.
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.
134 studies on the registry are indexed under Pneumoperitoneum; 28 are open to participants now.
This study's enrollment of 80 is close to the median of 76 across 77 interventional studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →Bagcilar Training and Research Hospital is the lead sponsor of 55 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Systolic Arterial Pressure
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
Change in Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO₂) was recorded and compared between groups
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Change in Bispectral Index
Bispectral Index (BIS) values were recorded to assess anesthetic depth and compared between groups
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Anesthetic Drug Cost
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 induction of anesthesia to completion of anesthesia
Diastolic Arterial Pressure
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
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
Heart rate was recorded in beats per minute at T0, T1, T2, T3, T4, and T5.
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Plan to share: No — Individual participant data will not be shared because no prospective data-sharing plan or consent for external sharing of individual-level data was established for this study.
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Studies of the drugs tested here: Propofol · Remifentanil
Bagcilar Training and Research Hospital