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NCT Number: NCT07155109

Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic 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.

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Key information

Conditions

Intracranial Pressure Increase Abdominal Pain Brain Diseases Central Nervous System Diseases Head Pain Headache Intracranial Hypertension Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low pressure group

Other

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

Normal pressure group

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Measurement of optic nerve sheath diameter (ONSD)

    Time frame: The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation

    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.

  2. Measurement of optic nerve sheath diameter (ONSD)

    Time frame: 5 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.

  3. Measurement of optic nerve sheath diameter (ONSD)

    Time frame: 60 minutes after introducing pneumoperitoneum and position change

    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.

  4. Measurement of optic nerve sheath diameter (ONSD)

    Time frame: 90 minutes after introducing pneumoperitoneum and position change

    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.

  5. 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.

    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.

Other outcomes

  1. numerical rating scale (NRS) at rest

    Time frame: popstoperative 1. hour

    Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient

  2. numerical rating scale (NRS) at rest

    Time frame: popstoperative 8. hours

    Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient

  3. postoperative nosia and vomiting (PONV)

    Time frame: popstoperative 1. hour

    Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively

  4. postoperative nosia and vomiting (PONV)

    Time frame: popstoperative 8. hours

    Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively

  5. headache

    Time frame: popstoperative 8. hours

    The presence or absence of headache will be assessed and documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep Koç

CONTACT

[email protected]

05345958843

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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