The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224532
• Other study ID #: 2019.10.103.072
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase
• Pneumoperitoneum

Intervention

Procedure:
• Pneumoperitoneum Timing (Before Positioning)
Before Reverse Trendelenburg Position
• Pneumoperitoneum Timing (After Positioning)
After Reverse Trendelenburg Position

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in regional cerebral oxygen saturation	The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.	Throughout the surgery
Secondary	Perioperative Hemodynamic Parameters	Mean arterial pressure in mmHg	Throughout the surgery
Secondary	Perioperative Hemodynamic Parameters	Heart rate beat per minute	Throughout the surgery