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Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries

The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07155109
Enrollment
100
Registered
2025-09-04
Start date
2025-08-30
Completion date
2025-10-20
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Head Pain, Intracranial Pressure Increase

Keywords

Intracranial Pressure, optic nerve, laparascopy, gyneco-oncologic surgery, low pressure

Brief 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.

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, we 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.

Interventions

In laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure.

OTHERNormal pressure group

In laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure.

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

The investigator will be blinded to whether low or intraperitoneal pressure is applied to the patients.

Intervention model description

In laparoscopic gyneco-oncological surgeries, one group will receive low intraperitoneal pressure, while the other group will receive standart intraperitoneal pressure.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Laparoscopic gyneco-oncological surgeries * Female patients aged 18-65 years * ASA physical status classification I-II-III patients

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of optic nerve sheath diameter (ONSD)30 minutes after introducing pneumoperitoneum and position changeONSD 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.

Secondary

MeasureTime frameDescription
Measurement of optic nerve sheath diameter (ONSD)The baseline ONSD measurement will be performed 5 minutes after endotracheal intubationONSD 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.

Other

MeasureTime frameDescription
numerical rating scale (NRS) at restpopstoperative 1. hourRecording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient
postoperative nosia and vomiting (PONV)popstoperative 1. hourRecording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively
headachepopstoperative 8. hoursThe presence or absence of headache will be assessed and documented.

Countries

Turkey (Türkiye)

Contacts

Primary ContactZeynep Koç
zeynepyilmazkoc@hotmail.com05345958843

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026