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

NCT06650475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • ONSD in Laparoscopic Surgery

Interventions

PROCEDURE

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).

Sponsors & Collaborators

  • Konya City Hospital

    lead OTHER

Principal Investigators

  • Yasin Tire, Assoc. Prof. · Konya City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2025-01-05
Completion
2025-01-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650475 on ClinicalTrials.gov