Clinical trial NCT04224532: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Pressure Increase
Pneumoperitoneum
Keywords: optic nerve sheath diameter
intracranial pressure
laparoscopic cholecystectomy
pneumoperitoneum
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-13
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Optic Nerve Sheath Diameter
timeFrame: Throughout the surgery
measure: Change in regional cerebral oxygen saturation
timeFrame: Throughout the surgery
Secondary outcomes:
measure: Perioperative Hemodynamic Parameters
timeFrame: Throughout the surgery
measure: Perioperative Hemodynamic Parameters
timeFrame: Throughout the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Serdar Demirgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.