The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position

Conditions
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Intracranial Pressure Increase, Pneumoperitoneum

Intervention / Treatment
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* Procedure: Pneumoperitoneum Timing (Before Positioning)
* Procedure: Pneumoperitoneum Timing (After Positioning)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group P<br>Pneumoperitoneum is induced before reverse Trendelenburg position. | Procedure: Pneumoperitoneum Timing (Before Positioning)<br>* Before Reverse Trendelenburg Position<br>|
| Experimental: Group RT<br>Pneumoperitoneum is induced after reverse Trendelenburg position. | Procedure: Pneumoperitoneum Timing (After Positioning)<br>* After Reverse Trendelenburg Position<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Hemodynamic Parameters | Mean arterial pressure in mmHg | Throughout the surgery | 
| Perioperative Hemodynamic Parameters | Heart rate beat per minute | Throughout the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optic nerve sheath diameter, intracranial pressure, laparoscopic cholecystectomy, pneumoperitoneum