Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2025-10-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intracranial Pressure Increase Abdominal Pain Head Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Low Pressure Group

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

Group Type EXPERIMENTAL

Low pressure group

Intervention Type OTHER

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

Normal Pressure Group

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

Group Type EXPERIMENTAL

Normal pressure group

Intervention Type OTHER

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

Interventions

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Low pressure group

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

Intervention Type OTHER

Normal pressure group

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes