Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries

NCT07155109 | Not Yet Recruiting

• 1 other identifier: ZeynepKoc005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Pressure Increase; Abdominal Pain; Head Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes after introducing pneumoperitoneum and position change

Secondary Outcomes (5)

• Measurement of optic nerve sheath diameter (ONSD)

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

• Measurement of optic nerve sheath diameter (ONSD)

  5 minutes after introducing pneumoperitoneum and position change

• Measurement of optic nerve sheath diameter (ONSD)

  60 minutes after introducing pneumoperitoneum and position change

• Measurement of optic nerve sheath diameter (ONSD)

  90 minutes after introducing pneumoperitoneum and position change

• Measurement of optic nerve sheath diameter (ONSD)

  The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.

Other Outcomes (5)

• numerical rating scale (NRS) at rest

  popstoperative 1. hour

• numerical rating scale (NRS) at rest

  popstoperative 8. hours

• postoperative nosia and vomiting (PONV)

  popstoperative 1. hour

Study Arms (2)

Low Pressure Group

EXPERIMENTAL

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

Other: Low pressure group

Normal Pressure Group

EXPERIMENTAL

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

Other: Normal pressure group

Interventions

Low pressure group OTHER

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

Low Pressure Group

Normal pressure group OTHER

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

Normal Pressure Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study will be conducted in gyneco-oncological surgeries. The patient group will consist exclusively of female patients.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Zeynep Koç

Yenimahalle, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33329767 BACKGROUND

• Geng 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.

  PMID: 33504329 BACKGROUND

• Kim 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.

  PMID: 26257848 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension; Abdominal Pain; Headache

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Zeynep Koç

CONTACT

05345958843; zeynepyilmazkoc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigator will be blinded to whether low or intraperitoneal pressure is applied to the patients.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

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

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: August 30, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 20, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

TU (1)