Intracranial PressureNCT07525648
Comparison of the Effects of Sevoflurane and Desflurane on Optic Nerve Sheath Diameter During Laparoscopic Surgery
A study testing Sevoflurane and Desflurane in people with Intracranial Pressure and Laparoscopic Surgery, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP). Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Intracranial Pressure, Laparoscopic Surgery, Optic Nerve Sheath Diameter
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Jul 2026
- Phase
- Interventional
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.
- ASA physical status I-II
Who cannot join
- Patients receiving beta-blocker or diuretic treatment.
- Patients with severe heart failure.
- Patients diagnosed with diabetes with ocular or neurological complications.
- Patients who have undergone cardiac surgery, eye surgery, brain surgery, or thoracic surgery.
- Patients with a history of hydrocephalus, glaucoma, intracranial mass, and stroke.
- History of allergy to the study drugs
- Known or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position
Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP).
Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP.
This prospective study aims to compare the effects of sevoflurane and desflurane on ONSD in patients undergoing laparoscopic hysterectomy and bilateral oophorectomy in the Trendelenburg position.
Read the detailed description
The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.
- Being tested
- Sevoflurane, Desflurane
- Keywords
- Sevoflurane, Desflurane, Trendelenburg Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Anesthesia maintenance will be provided with sevoflurane at 1 MAC in a 40% oxygen-air mixture.
DesfluraneDrug
Anesthesia maintenance will be provided with desflurane at 1 MAC in a 40% oxygen-air mixture.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Sevo) | Active comparator | Anaesthesia maintenance with sevoflurane titrated to 1.0 MAC in 40% oxygen / 60% air. Receives: Drug: Sevoflurane |
| Group 2 (Des) | Active comparator | Anaesthesia maintenance with desflurane titrated to 1.0 MAC in 40% oxygen / 60% air. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter (ONSD)
ONSD measured by transorbital ultrasound with a 7.5-15 MHz linear probe, 3.0 mm behind the posterior globe wall, between the outer edges of the dural sheath. At least three measurements are obtained from each eye and averaged.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Secondary outcomes (8)
Mean Arterial Pressure (MAP)
Mean arterial pressure will be measured via non-invasive blood pressure monitoring or invasive radial artery cannulation.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Peripheral Oxygen Saturation (SpO2)
Oxygen saturation will be monitored continuously using pulse oximetry.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
End-tidal Carbon Dioxide (EtCO2)
End-tidal carbon dioxide levels will be measured using capnography monitoring.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Arterial pH
Arterial pH levels will be evaluated from arterial blood gas analysis samples.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Partial Pressure of Carbon Dioxide (pCO2)
pCO2 levels will be evaluated from arterial blood gas analysis samples.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Change in optic nerve sheath diameter between consecutive study phases (Δ ONSD)
Within-patient change in ONSD between consecutive time points (Δ T1-T2, Δ T2-T3, Δ T3-T4, Δ T4-T5) and across the whole procedure (Δ T1-T4, Δ T1-T5), compared between the sevoflurane and desflurane groups.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Arterial lactate
Arterial lactate measured from arterial blood gas samples.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Peak airway pressure
Peak inspiratory airway pressure recorded from the anaesthesia ventilator.
Measured: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Apr 2026
- Primary completion5 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
- Investigators
- Burak Ömür, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525648
- Sponsor's protocol ID
- 191 - 2025
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analysed during the current study are not publicly available because the participants did not consent to public data sharing, but are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position
- ClinicalTrials.gov ID
- NCT07525648
- Acronym / sponsor ID
- 191 - 2025
- Keywords
- Sevoflurane, Desflurane, Trendelenburg Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 13 Apr 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.
Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP).
Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP.
This prospective study aims to compare the effects of sevoflurane and desflurane on ONSD in patients undergoing laparoscopic hysterectomy and bilateral oophorectomy in the Trendelenburg position.
Detailed description
The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Sevo) | Active comparator | Drug: SevofluraneAnaesthesia maintenance with sevoflurane titrated to 1.0 MAC in 40% oxygen / 60% air. |
| Group 2 (Des) | Active comparator | Drug: DesfluraneAnaesthesia maintenance with desflurane titrated to 1.0 MAC in 40% oxygen / 60% air. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.
- ASA physical status I-II
Key exclusion criteria (7 listed)
- Patients receiving beta-blocker or diuretic treatment.
- Patients with severe heart failure.
- Patients diagnosed with diabetes with ocular or neurological complications.
- Patients who have undergone cardiac surgery, eye surgery, brain surgery, or thoracic surgery.
- Patients with a history of hydrocephalus, glaucoma, intracranial mass, and stroke.
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 |
|---|---|---|
| SevofluraneAnesthesia maintenance will be provided with sevoflurane at 1 MAC in a 40% oxygen-air mixture. | Drug | Group 1 (Sevo) |
| DesfluraneAnesthesia maintenance will be provided with desflurane at 1 MAC in a 40% oxygen-air mixture. | Drug | Group 2 (Des) |
Primary outcome
Optic Nerve Sheath Diameter (ONSD)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
ONSD measured by transorbital ultrasound with a 7.5-15 MHz linear probe, 3.0 mm behind the posterior globe wall, between the outer edges of the dural sheath. At least three measurements are obtained from each eye and averaged.
8 secondary outcomes
Mean Arterial Pressure (MAP)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Peripheral Oxygen Saturation (SpO2)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
End-tidal Carbon Dioxide (EtCO2)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Arterial pH
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Partial Pressure of Carbon Dioxide (pCO2)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Change in optic nerve sheath diameter between consecutive study phases (Δ ONSD)
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Arterial lactate
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
Peak airway pressure
Time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine
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 4 Aug 2026.
- Individual participant dataSharing planned: Undecided. The datasets generated and analysed during the current study are not publicly available because the participants did not consent to public data sharing, but are available from the corresponding author on reasonable request.
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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.
Burak Ömür principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Desflurane in people with Intracranial Pressure and Laparoscopic Surgery, run by Medipol University 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 2 inclusion and 7 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 4 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.
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?
Optic Nerve Sheath Diameter (ONSD) (time frame: T1: after intubation, before 1.0 MAC (supine); T2: on reaching 1.0 MAC (supine); T3: 10 min after pneumoperitoneum and steep Trendelenburg; T4: 60 min after pneumoperitoneum and steep Trendelenburg; T5: 10 min after desufflation, supine). 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 4 Aug 2026.