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The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

Primary Purpose

Intracranial Pressure Increase, Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pneumoperitoneum Timing (Before Positioning)
Pneumoperitoneum Timing (After Positioning)
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Pressure Increase focused on measuring optic nerve sheath diameter, intracranial pressure, laparoscopic cholecystectomy, pneumoperitoneum

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bagcilar Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group P

Group RT

Arm Description

Pneumoperitoneum is induced before reverse Trendelenburg position.

Pneumoperitoneum is induced after reverse Trendelenburg position.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perioperative Hemodynamic Parameters
Mean arterial pressure in mmHg
Perioperative Hemodynamic Parameters
Heart rate beat per minute

Full Information

First Posted
January 8, 2020
Last Updated
June 3, 2020
Sponsor
Bagcilar Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04224532
Brief Title
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy
Official Title
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase, Pneumoperitoneum
Keywords
optic nerve sheath diameter, intracranial pressure, laparoscopic cholecystectomy, pneumoperitoneum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group P
Arm Type
Experimental
Arm Description
Pneumoperitoneum is induced before reverse Trendelenburg position.
Arm Title
Group RT
Arm Type
Experimental
Arm Description
Pneumoperitoneum is induced after reverse Trendelenburg position.
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum Timing (Before Positioning)
Intervention Description
Before Reverse Trendelenburg Position
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum Timing (After Positioning)
Intervention Description
After Reverse Trendelenburg Position
Primary Outcome Measure Information:
Title
Change in Optic Nerve Sheath Diameter
Description
The change in intracranial pressure via optic nerve sheath diameter measurement during laparoscopic cholecystectomy among 6 time point.
Time Frame
Throughout the surgery
Title
Change in regional cerebral oxygen saturation
Description
The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.
Time Frame
Throughout the surgery
Secondary Outcome Measure Information:
Title
Perioperative Hemodynamic Parameters
Description
Mean arterial pressure in mmHg
Time Frame
Throughout the surgery
Title
Perioperative Hemodynamic Parameters
Description
Heart rate beat per minute
Time Frame
Throughout the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Demirgan, MD
Organizational Affiliation
Bagcilar Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bagcilar Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34200
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27956677
Citation
Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
Results Reference
background
PubMed Identifier
25899811
Citation
Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.
Results Reference
background
PubMed Identifier
28918894
Citation
Sahay N, Sharma S, Bhadani UK, Singh A, Sinha C, Sahay A, Ranjan A, Agarwal M. Effect of Pneumoperitoneum and Patient Positioning on Intracranial Pressures during Laparoscopy: A Prospective Comparative Study. J Minim Invasive Gynecol. 2018 Jan;25(1):147-152. doi: 10.1016/j.jmig.2017.07.031. Epub 2017 Sep 12.
Results Reference
background
PubMed Identifier
33089454
Citation
Demirgan S, Ozcan FG, Gemici EK, Guneyli HC, Yavuz E, Gulcicek OB, Selcan A. Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial. J Clin Monit Comput. 2021 Feb;35(1):89-99. doi: 10.1007/s10877-020-00608-6. Epub 2020 Oct 21.
Results Reference
derived

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The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

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