Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650475
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Optic Nerve Sheath Diameter Low vs Conventional Insufflation Pressures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Optic Nerve Sheath Diameter in Children Undergoing Laparoscopic Abdominal Surgery at Low and Standard Gas Insufflation Pressures
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective This study investigates the impact of carbon dioxide CO2 pneumoperitoneum on optic nerve sheath diameter ONSD and intracranial pressure ICP in patients undergoing total laparoscopic hysterectomy Previous research suggests that pneumoperitoneum can lead to elevated ICP with the standard intracranial monitoring technique being invasive intraventricular catheter placement In contrast bedside ultrasound assessment of ONSD offers a noninvasive alternative for detecting increased ICP
Methods We hypothesize that standard gas insufflation pressure significantly increases ONSD while low-pressure insufflation will maintain ONSD levels The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery Secondary aims include evaluating end-tidal CO2 measurements between the two groups
Methods We hypothesize that standard gas insufflation pressure significantly increases ONSD while low-pressure insufflation will maintain ONSD levels The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery Secondary aims include evaluating end-tidal CO2 measurements between the two groups
Detailed Description:
It has been shown in many studies that pneumoperitoneum containing carbon dioxide CO2 during laparoscopy increases intracranial pressure ICP 1 Evaluation of the Effect of Intraabdominal Pressure on Optic Nerve Sheath Diameter in Patients Undergoing Total Laparoscopic Hysterectomy The standard technique for monitoring ICP is the placement of an intraventricular catheter connected to an external pressure transducer 2 Bedside evaluation of optic nerve sheath diameter ONSD with ultrasound technique is a more practical and noninvasive method used to determine high ICP 20 mmHg The anatomical continuity of the dura with the optic nerve sheath ONSD allows the use of this technology and thus an increase in ICP can be transmitted from the subarachnoid space to the ONSD 3
Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified 4
In our thesis assuming that standard gas insufflation pressure will increase ONSD but low gas insufflation pressure will not cause a change the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively Second the end-tidal CO2 measurements between the two groups will be evaluated
Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified 4
In our thesis assuming that standard gas insufflation pressure will increase ONSD but low gas insufflation pressure will not cause a change the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively Second the end-tidal CO2 measurements between the two groups will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None