Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609993
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
AoA Guided Thoracic Epidural Analgesia for Abdominal Aortic Repair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Thoracic Epidural Analgesia Using Bupivacaine or Ropivacaine With Fentanyl in Patients Undergoing Abdominal Aorctic Repair Under Adequacy of Anaestesia Guidance
Status:
COMPLETED
Status Verified Date:
2024-09
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:
AoA-AAA
Brief Summary:
The aim of this randomized trial is to assess the efficacy of analgesia using either thoracic epidural or intravenous infusions for open lumbar infrarenal aortic aneurys repair and compare Numerical Rating Scale NRS with Surgical Pleth Index SPI for monitoring pain perception postoperatively
Patients received either preemptive thoracic epidural analgesia using either 02 ropivacaine with fentanyl or 02 bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol
Patients received either preemptive thoracic epidural analgesia using either 02 ropivacaine with fentanyl or 02 bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol
Detailed Description:
Open major abdominal surgery is one of the most risky surgical procedures performed under general anaesthesia GA for inappropriate postoperative pain perception IPPP whereas thoracic epidural analgesia TEA still constitutes the golden standard of analgesic regimen in the upper abdomen because its was proven to provide improved postoperative analgesia reduce the incidence of chronic postoperative pain as compared with parenteral opioids Therefore it should always be considered as a routine adjunct to GA for elective open lumbar infrarenal aortic repair OLIAAR Monitors of analgesia that measure nociception antinociception balance - intensity of nociception painful stimulation and efficacy of anti-nociception pain relief - are increasingly gaining popularity The Adequacy o Anesthesia AoA concept is based on monitoring the depth of GA detected from a forehead sensor using an entropy electroencephalogram Response Entropy RE State Entropy SE and the surgical pleth index SPI derived from a finger photoplethysmography signal both of which do not require complex preoperative preparations Observance of the SE value within the range of 40-60 as a result of proper administration of the hypnotic GA component reflecting the proper suppression of the limbic system alongside observance of the increase in the SPI value on the monitor 0-no painful stimulation 100-maximum painful stimulation after a painful stimulus and returning to the baseline level after the intravenous rescue opioid analgesia IROA bolus anti-nociception makes the monitoring with AoA guidance easy SPI has been successfully used to monitor analgesia intra- and postoperatively and less postoperative pain have already been reported when SPI monitoring was employed Considering all the above the investigators designed a randomised controlled study to assess the effect of TEA using a combination of either 02 ropivacaine RPV and fentanyl FNT or 02 bupivacaine BPV and FNT on intra- and postoperative demand for opioids haemodynamic stability as compared to intravenous preventive analgesia using metamizoletramadol in patients undergoing open lumbar infrarenal aortic aneurysm repair OLIAAR under AoA-guided GA
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