Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04500249
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2019-04-14
Brief Title:
SPI-guided Analgesia During CEA Under RA
Sponsor:
Medical University of Silesia
Organization:
Medical University of Silesia
Study Overview
Official Title:
SPI-guided Analgesia in Patients Undergoing Carotid Endarterectomy Under Cervical Plexus Block
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
CEA
Brief Summary:
The aim of this randomized prospective trial is to assess the utility of Adequacy of Anaesthesia technique Response Entropy and Surgical Pleth Index for monitoring pain perception intraoperatively maintainance of hemodynamic stability during anesthesia and its influence on postoperative outcomes in patients undergoing carotid endarterectomy under cervical plexus block
Detailed Description:
Carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid endarterectomy is performed to protects patients with severe atherosclerotic carotid artery stenosis against stroke
Surgical Pleth Index SPI is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level values near 50 or increase in value delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia
A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block
Surgical Pleth Index SPI is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level values near 50 or increase in value delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia
A randomized interventional trial to evaluate the effects of SPI-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block
Study Oversight
Has Oversight DMC:
None
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?:
None