drugset / Trial / NCT04648540

Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: RCT

NCT04648540

Phase 0 Completed 60 enrolled Cairo University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively . Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible. On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries. The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery

Timeline

Start
2020-12-01
Primary completion
2022-08-01
Completion
2022-10-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1 g Intravenous
Subject Celecoxib Other / unclassified 200 mg
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 1 ug/kg
Subject Ketorolac Other / unclassified 30 mg Intravenous
Subject Lidocaine Other / unclassified 0.5 mg/kg Intravenous
Subject Pregabalin Small molecule 150 mg Oral
Comparator Morphine Other / unclassified 0.1 mg/kg

Indications

No indication recorded.