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Completed

NCT Number: NCT04224532

The Effect of Pneumoperitoneum Timing on Intracranial Pressure in 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.

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Key information

Conditions

Intracranial Pressure Increase Brain Diseases Central Nervous System Diseases Digestive System Diseases Intracranial Hypertension Nervous System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumoperitoneum Timing (Before Positioning)

Procedure

Before Reverse Trendelenburg Position

Pneumoperitoneum Timing (After Positioning)

Procedure

After Reverse Trendelenburg Position

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter

    Time frame: Throughout the surgery

    The change in intracranial pressure via optic nerve sheath diameter measurement during laparoscopic cholecystectomy among 6 time point.

  2. Change in regional cerebral oxygen saturation

    Time frame: Throughout the surgery

    The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.

Secondary outcomes

  1. Perioperative Hemodynamic Parameters

    Time frame: Throughout the surgery

    Mean arterial pressure in mmHg

  2. Perioperative Hemodynamic Parameters

    Time frame: Throughout the surgery

    Heart rate beat per minute

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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