Intracranial Pressure IncreaseNCT07155109
Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries
A study testing Low pressure group and Normal pressure group in people with Intracranial Pressure Increase and Abdominal Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase, Abdominal Pain, Head Pain
- What is being tested?
- Low pressure group and Normal pressure group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 20 Mar 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laparoscopic gyneco-oncological surgeries
- Female patients aged 18-65 years
- ASA physical status classification I-II-III patients
Who cannot join
- Patients with diabetic retinopathy
- Patients with glaucoma
- Patients with cerebrovascular disease
- Pregnant women
- Patients with known allergy to anaesthetic agents
- Morbidly obese patients with BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries.
Read the detailed description
Gynecological surgeries are minimally invasive procedures. The establishment of pneumoperitoneum, special patient positioning, and surgical stimulation can induce a stress response in patients. Carbon dioxide (CO₂) pneumoperitoneum and the Trendelenburg position lead to increases in intra-abdominal, intrathoracic, and airway pressures, which in turn may directly or indirectly cause elevations in intracranial and intraocular pressures.
During the perioperative period, the optic nerve sheath diameter (ONSD), measured ultrasonographically, is used as a reliable method to estimate intracranial pressure (ICP). Monitoring ICP under anesthesia may help prevent neurological complications such as neurological deterioration and optic neuropathy. Furthermore, studies have demonstrated ICP changes in robotic and laparoscopic gynecologic surgeries through ultrasonographic measurement of ONSD.
Traditionally, laparoscopic abdominal surgeries are performed using intraperitoneal pressures ranging between 10 and 18 mmHg. Lower intra-abdominal pressures have been associated with reduced postoperative pain, improved pulmonary parameters, and a decreased risk of gas embolism. However, the data on these outcomes remain limited.
In this study, investigators aimed to investigate the effect of pressures above and below 12 mmHg on the optic nerve sheath diameter-and consequently on intracranial pressure-in patients undergoing laparoscopic gynecologic surgery.
- Conditions
- Intracranial Pressure Increase, Abdominal Pain, Head Pain
- Being tested
- Low pressure group, Normal pressure group
- Keywords
- Intracranial Pressure, optic nerve, laparascopy, gyneco-oncologic surgery, low pressure
- Medical subject headings
- Intracranial Hypertension, Abdominal Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low pressure groupOther
In laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure.
Normal pressure groupOther
In laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure.
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure Group | Experimental | In laparoscopic gyneco-oncological surgeries, low pressure group received below 12 mmHg intraperitoneal pressure. Receives: Other: Low pressure group |
| Normal Pressure Group | Experimental | In laparoscopic gyneco-oncological surgeries, normal pressure group received 12 and abowe 12 mmHg intraperitoneal pressure. Receives: Other: Normal pressure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: 30 minutes after introducing pneumoperitoneum and position change
Secondary outcomes (5)
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: 5 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: 60 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: 90 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
Measured: The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start30 Aug 2025
- Primary completion10 Feb 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In laparoscopic gyneco-oncological surgeries, one group will receive low intraperitoneal pressure, while the other group will receive standart intraperitoneal pressure.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeynep Koc, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155109
- Sponsor's protocol ID
- ZeynepKoc005
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee YY, Lee H, Park HS, Kim WJ, Baik HJ, Kim DY. Optic nerve sheath diameter changes during gynecologic surgery in the Trendelenburg position: comparison of propofol-based total intravenous anesthesia and sevoflurane anesthesia. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):393-400. doi: 10.17085/apm.2019.14.4.393.
PubMed 33329767Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.
PubMed 33504329Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015 Aug;68(4):358-63. doi: 10.4097/kjae.2015.68.4.358. Epub 2015 Jul 28.
PubMed 26257848
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries
- ClinicalTrials.gov ID
- NCT07155109
- Acronym / sponsor ID
- ZeynepKoc005
- Conditions
- Intracranial Pressure Increase, Abdominal Pain, Head Pain
- Keywords
- Intracranial Pressure, optic nerve, laparascopy, gyneco-oncologic surgery, low pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 4 Sep 2025 (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.
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries.
Detailed description
Gynecological surgeries are minimally invasive procedures. The establishment of pneumoperitoneum, special patient positioning, and surgical stimulation can induce a stress response in patients. Carbon dioxide (CO₂) pneumoperitoneum and the Trendelenburg position lead to increases in intra-abdominal, intrathoracic, and airway pressures, which in turn may directly or indirectly cause elevations in intracranial and intraocular pressures.
During the perioperative period, the optic nerve sheath diameter (ONSD), measured ultrasonographically, is used as a reliable method to estimate intracranial pressure (ICP). Monitoring ICP under anesthesia may help prevent neurological complications such as neurological deterioration and optic neuropathy. Furthermore, studies have demonstrated ICP changes in robotic and laparoscopic gynecologic surgeries through ultrasonographic measurement of ONSD.
Traditionally, laparoscopic abdominal surgeries are performed using intraperitoneal pressures ranging between 10 and 18 mmHg. Lower intra-abdominal pressures have been associated with reduced postoperative pain, improved pulmonary parameters, and a decreased risk of gas embolism. However, the data on these outcomes remain limited.
In this study, investigators aimed to investigate the effect of pressures above and below 12 mmHg on the optic nerve sheath diameter-and consequently on intracranial pressure-in patients undergoing laparoscopic gynecologic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In laparoscopic gyneco-oncological surgeries, one group will receive low intraperitoneal pressure, while the other group will receive standart intraperitoneal pressure.
| Arm | Type | Receives |
|---|---|---|
| Low Pressure Group | Experimental | Other: Low pressure groupIn laparoscopic gyneco-oncological surgeries, low pressure group received below 12 mmHg intraperitoneal pressure. |
| Normal Pressure Group | Experimental | Other: Normal pressure groupIn laparoscopic gyneco-oncological surgeries, normal pressure group received 12 and abowe 12 mmHg intraperitoneal pressure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laparoscopic gyneco-oncological surgeries
- Female patients aged 18-65 years
- ASA physical status classification I-II-III patients
Key exclusion criteria (6 listed)
- Patients with diabetic retinopathy
- Patients with glaucoma
- Patients with cerebrovascular disease
- Pregnant women
- Patients with known allergy to anaesthetic agents
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 |
|---|---|---|
| Low pressure groupIn laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure. | Other | Low Pressure Group |
| Normal pressure groupIn laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure. | Other | Normal Pressure Group |
Primary outcome
Measurement of optic nerve sheath diameter (ONSD)
Time frame: 30 minutes after introducing pneumoperitoneum and position change
ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.
5 secondary outcomes
Measurement of optic nerve sheath diameter (ONSD)
Time frame: The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation
Measurement of optic nerve sheath diameter (ONSD)
Time frame: 5 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
Time frame: 60 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
Time frame: 90 minutes after introducing pneumoperitoneum and position change
Measurement of optic nerve sheath diameter (ONSD)
Time frame: The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.
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 15 Oct 2026.
- Background: PubMed 33329767Lee YY, Lee H, Park HS, Kim WJ, Baik HJ, Kim DY. Optic nerve sheath diameter changes during gynecologic surgery in the Trendelenburg position: comparison of propofol-based total intravenous anesthesia and sevoflurane anesthesia. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):393-400. doi: 10.17085/apm.2019.14.4.393.
- Background: PubMed 33504329Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.
- Background: PubMed 26257848Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015 Aug;68(4):358-63. doi: 10.4097/kjae.2015.68.4.358. Epub 2015 Jul 28.
- Individual participant dataSharing planned: Undecided
Related trials for Intracranial Pressure Increase
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
Not yet recruitingObservational study
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Traumatic Brain Injury
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Active, not recruitingObservational study
TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI
Intracranial Pressure Increase, Traumatic Brain Injuries
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 study testing Low pressure group and Normal pressure group in people with Intracranial Pressure Increase and Abdominal Pain, run by Diskapi Yildirim Beyazit Education 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 3 inclusion and 6 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 15 Oct 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?
Measurement of optic nerve sheath diameter (ONSD) (time frame: 30 minutes after introducing pneumoperitoneum and position change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07155109, which also lists 3 linked publications.
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 15 Oct 2026.