Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT03417193
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid Free Anesthesia and Major Spine Surgery
Sponsor:
Lebanese American University
Organization:
Study Overview
Official Title:
Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
Detailed Description:
Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects.
Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .
Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.
Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .
Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.
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?: