"Optic Nerve Sheath Diameter; Low vs. Conventional Insufflation Pressures''

NCT ID: NCT06650475

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2025-01-10

Brief Summary

Objective: This study investigates the impact of carbon dioxide (CO2) pneumoperitoneum on optic nerve sheath diameter (ONSD) and intracranial pressure (ICP) in patients undergoing total laparoscopic hysterectomy. Previous research suggests that pneumoperitoneum can lead to elevated ICP, with the standard intracranial monitoring technique being invasive intraventricular catheter placement. In contrast, bedside ultrasound assessment of ONSD offers a noninvasive alternative for detecting increased ICP.

Methods: The Hypothesize will be standard gas insufflation pressure significantly increases ONSD, while low-pressure insufflation will maintain ONSD levels. The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery. Secondary aims include evaluating end-tidal CO2 measurements between the two groups.

Detailed Description

It has been shown in many studies that pneumoperitoneum containing carbon dioxide (CO2) during laparoscopy increases intracranial pressure (ICP). (1) Evaluation of the Effect of Intraabdominal Pressure on Optic Nerve Sheath Diameter in Patients Undergoing Total Laparoscopic Hysterectomy. The standard technique for monitoring ICP is the placement of an intraventricular catheter connected to an external pressure transducer. (2) Bedside evaluation of optic nerve sheath diameter (ONSD) with ultrasound technique is a more practical and noninvasive method used to determine high ICP (>20 mmHg). The anatomical continuity of the dura with the optic nerve sheath (ONSD) allows the use of this technology, and thus an increase in ICP can be transmitted from the subarachnoid space to the ONSD. (3)

Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies, but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified. (4)

In our thesis, assuming that standard gas insufflation pressure will increase ONSD, but low gas insufflation pressure will not cause a change, the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively. Second, the end-tidal CO2 measurements between the two groups will be evaluated.

Conditions

ONSD in Laparoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standart Pressure

Standard pressures (12-16 mmHg) are used in laparoscopic surgery for patients in Group S.

Group Type: SHAM_COMPARATOR

Using low or standart pressure

Intervention Type: PROCEDURE

Written consent will be obtained before the randomized study. Randomization will be done on the computer using a software program. Participants will be divided into two groups. Patients in Group S will undergo laparoscopy under standard pressures (12-16 mmHg) in laparoscopic surgery, while patients in Group L will undergo laparoscopy under low pressure (8-10 mm Hg).

Low pressure

Group L will undergo laparoscopy under low pressure (8-10mm Hg).

Group Type: ACTIVE_COMPARATOR

Using low or standart pressure

Intervention Type: PROCEDURE

Written consent will be obtained before the randomized study. Randomization will be done on the computer using a software program. Participants will be divided into two groups. Patients in Group S will undergo laparoscopy under standard pressures (12-16 mmHg) in laparoscopic surgery, while patients in Group L will undergo laparoscopy under low pressure (8-10 mm Hg).

Interventions

Using low or standart pressure

Written consent will be obtained before the randomized study. Randomization will be done on the computer using a software program. Participants will be divided into two groups. Patients in Group S will undergo laparoscopy under standard pressures (12-16 mmHg) in laparoscopic surgery, while patients in Group L will undergo laparoscopy under low pressure (8-10 mm Hg).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The study will be conducted in patients under 18 years of age with American Society of Anesthesiologists (ASA) I-II.

Exclusion Criteria

• Patients with a history of neurological disease, glaucoma, surgery exceeding 2 hours, known chronic obstructive pulmonary disease (COPD), heart disease, and previous lung surgery will be excluded from the study. Patients with intraoperative hemodynamic problems; ETCO2 greater than 45 mmHg, plateau pressure over 30 cmH2, and peak inspiratory pressure over 35 cmH2 will be excluded from the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Tire, MD

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasin Tire, Assoc. Prof.

Role: STUDY_DIRECTOR

Konya City Hospital

Locations

Konya City Hospital

Konya, Meram, Turkey (Türkiye)

Yasin Tire

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Study Pedlap

Identifier Type: -

Identifier Source: org_study_id