Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 10:26 AM
Study NCT ID:
NCT04224532
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy
Sponsor:
Bagcilar Training and Research Hospital
Organization:
Study Overview
Official Title:
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: