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The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy

B

Bagcilar Training and Research Hospital

Status

Completed

Conditions

Pneumoperitoneum
Intracranial Pressure Increase

Treatments

Procedure: Pneumoperitoneum Timing (Before Positioning)
Procedure: Pneumoperitoneum Timing (After Positioning)

Study type

Interventional

Funder types

Other

Identifiers

NCT04224532
2019.10.103.072

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

79 participants in 2 patient groups

Group P
Experimental group
Description:
Pneumoperitoneum is induced before reverse Trendelenburg position.
Treatment:
Procedure: Pneumoperitoneum Timing (Before Positioning)
Group RT
Experimental group
Description:
Pneumoperitoneum is induced after reverse Trendelenburg position.
Treatment:
Procedure: Pneumoperitoneum Timing (After Positioning)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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