Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437886
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-31
First Post:
2024-05-22
Brief Title:
High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery
Sponsor:
Chinese Academy of Medical Sciences Fuwai Hospital
Organization:
Chinese Academy of Medical Sciences Fuwai Hospital
Study Overview
Official Title:
Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
BACKGROUND In cardiac surgery high-dose opioid contributes to adverse events associated with poor postoperative outcomes There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve patients early postoperative recovery
OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery
DESIGN A randomised controlled trial SETTING A tertiary hospital PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use
INTERVENTIONS Eligible patients were randomised at a 11 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block intervention group or opioid-based anaesthesia control group
MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery QoR-15 questionnaire at 24h after surgery Secondary outcomes included QoR-15 at 72h after surgery postoperative pain score the incidence of postoperative adverse events and chronic pain Other outcomes included endotracheal intubation duration length of hospitalization and hospital costs
OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery
DESIGN A randomised controlled trial SETTING A tertiary hospital PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use
INTERVENTIONS Eligible patients were randomised at a 11 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block intervention group or opioid-based anaesthesia control group
MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery QoR-15 questionnaire at 24h after surgery Secondary outcomes included QoR-15 at 72h after surgery postoperative pain score the incidence of postoperative adverse events and chronic pain Other outcomes included endotracheal intubation duration length of hospitalization and hospital costs
Detailed Description:
None
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