The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

Not Applicable

Completed

• Conditions: Pneumoperitoneum; Intracranial Pressure Increase
• Interventions: Procedure: Pneumoperitoneum Timing (Before Positioning); Procedure: Pneumoperitoneum Timing (After Positioning)

• Registration Number: NCT04224532
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.

Detailed Description

The literature includes studies that investigate the relationship of pneumoperitoneum and different positions with intracranial pressure during laparoscopy. Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation. Ultrasound guided measurement of the optic nerve sheath diameter as a non-invasive method will be used for measurement. The investigators believe reverse Trendelenburg position before pneumoperitoneum may prevent undesired sudden increases in intracranial pressure.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-08
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Undergoing laparoscopic cholecystectomy operation
• Age between 18-65
• ASA I-II
• BMI ≤ 35

Exclusion Criteria

• Ophthalmologic disease and optic nerve pathology
• Increased intracranial pressure
• History of cerebrovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Pneumoperitoneum Timing (Before Positioning)	Pneumoperitoneum is induced before reverse Trendelenburg position.
Group RT	Pneumoperitoneum Timing (After Positioning)	Pneumoperitoneum is induced after reverse Trendelenburg position.

Primary Outcome Measures

Name	Time	Method
Change in Optic Nerve Sheath Diameter	Throughout the surgery	The change in intracranial pressure via optic nerve sheath diameter measurement during laparoscopic cholecystectomy among 6 time point.
Change in regional cerebral oxygen saturation	Throughout the surgery	The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.

Secondary Outcome Measures

Name	Time	Method
Perioperative Hemodynamic Parameters	Throughout the surgery	Heart rate beat per minute

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital; 🇹🇷 Istanbul, Turkey