The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04224532

Enrollment

Registered

2020-01-13

Start date

2020-01-08

Completion date

2020-03-01

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Increase, Pneumoperitoneum

Keywords

optic nerve sheath diameter, intracranial pressure, laparoscopic cholecystectomy, pneumoperitoneum

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.

Interventions

PROCEDUREPneumoperitoneum Timing (Before Positioning)

Before Reverse Trendelenburg Position

PROCEDUREPneumoperitoneum Timing (After Positioning)

After Reverse Trendelenburg Position

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Perioperative Hemodynamic Parameters	Throughout the surgery	Mean arterial pressure in mmHg

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026