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Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries

D

Diskapi Yildirim Beyazit Training and Research Hospital

Status

Not yet enrolling

Conditions

Intracranial Pressure Increase
Head Pain
Abdominal Pain

Treatments

Other: Low pressure group
Other: Normal pressure group

Study type

Interventional

Funder types

Other

Identifiers

NCT07155109
ZeynepKoc005

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

100 participants in 2 patient groups

Low Pressure Group
Experimental group
Description:
In laparoscopic gyneco-oncological surgeries, low pressure group received below 12 mmHg intraperitoneal pressure.
Treatment:
Other: Low pressure group
Normal Pressure Group
Experimental group
Description:
In laparoscopic gyneco-oncological surgeries, normal pressure group received 12 and abowe 12 mmHg intraperitoneal pressure.
Treatment:
Other: Normal pressure group

Trial contacts and locations

1

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Central trial contact

Zeynep Koç

Data sourced from clinicaltrials.gov

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