Intracranial Pressure ChangePhase 4NCT07786740
VIMA vs TIVA and ONSD in Laparoscopic Cholecystectomy
A Phase 4 study testing Propofol (Astra-Zeneca), Remifentanil and Sevofluorane in people with Intracranial Pressure Change and Optic Nerve Diameter, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Pressure Change, Optic Nerve Diameter
- What is being tested?
- Propofol (Astra-Zeneca), Remifentanil and Sevofluorane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 5 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Provided written informed consent to participate
Who cannot join
- 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
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- Hepatic dysfunction
- Renal dysfunction
- Pregnancy or lactation
- Intracranial space-occupying lesion or any condition predisposing to increased intracranial pressure
- Known optic nerve pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Isntabul Bagcilar Research and Training Hospital
Istanbul
About this study
Official title: Volatile Versus Total Intravenous Anesthesia and Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Intracranial Pressure Change, Optic Nerve Diameter
- Being tested
- Propofol (Astra-Zeneca), Remifentanil, Sevofluorane
- Keywords
- optic nerve sheath diameter, total intravenous anesthesia, sevoflurane, propofol, laparoscopic cholecystectomy, pneumoperitoneum, intracranial pressure
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
RemifentanilDrug
Remifentanil was administered as a continuous intravenous infusion at 0.1 µg/kg/min during maintenance of anesthesia in the TIVA group.
SevofluoraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sevofluorane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From before induction of anesthesia to 5 minutes after desufflation
Secondary outcomes (7)
Systolic Arterial Pressure
Systolic arterial pressure were recorded and compared between the TIVA and VIMA groups.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From before induction of anesthesia to 5 minutes after desufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jan 2023
- Primary completion1 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel anesthesia groups: total intravenous anesthesia (TIVA) or volatile induction and maintenance anesthesia (VIMA).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Serdar Demirgan, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786740
- Sponsor's protocol ID
- 2022/378
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Versus Total Intravenous Anesthesia and Optic Nerve Sheath Diameter During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07786740
- Acronym / sponsor ID
- 2022/378
- Conditions
- Intracranial Pressure Change, Optic Nerve Diameter
- Keywords
- optic nerve sheath diameter, total intravenous anesthesia, sevoflurane, propofol, laparoscopic cholecystectomy, pneumoperitoneum, intracranial pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel anesthesia groups: total intravenous anesthesia (TIVA) or volatile induction and maintenance anesthesia (VIMA).
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Experimental | Drug: Propofol (Astra-Zeneca), Drug: RemifentanilAnesthesia 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. |
| Volatile Induction and Maintenance Anesthesia (VIMA) | Active comparator | Drug: SevofluoraneAnesthesia 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Provided written informed consent to participate
Key exclusion criteria (11 listed)
- Refusal to participate
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- History of malignancy
- Severe cardiovascular disease, including congestive heart failure or myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol (Astra-Zeneca)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. | Drug | Total Intravenous Anesthesia (TIVA) |
| RemifentanilRemifentanil was administered as a continuous intravenous infusion at 0.1 µg/kg/min during maintenance of anesthesia in the TIVA group. | Drug | Total Intravenous Anesthesia (TIVA) |
| SevofluoraneSevoflurane 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. | Drug | Volatile Induction and Maintenance Anesthesia (VIMA) |
Primary outcome
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.
7 secondary outcomes
Systolic Arterial Pressure
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Change in Peripheral Oxygen Saturation
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Change in Bispectral Index
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Anesthetic Drug Cost
Time frame: From induction of anesthesia to completion of anesthesia
Diastolic Arterial Pressure
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Mean Arterial Pressure
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Heart Rate
Time frame: From before induction of anesthesia to 5 minutes after desufflation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol (Astra-Zeneca), Remifentanil and Sevofluorane in people with Intracranial Pressure Change and Optic Nerve Diameter, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optic Nerve Sheath Diameter During the Perioperative Period (time frame: From before induction of anesthesia to 5 minutes after desufflation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.