NCT04197570

Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare an opioid free anesthetic, using dexmedetomidine, to a traditional opioid based anesthetic, using fentanyl, for patients undergoing cardiac surgery with regards to hemodynamic stability in the first 10 minutes after induction.

Detailed description

This is a single center, blinded, prospective, randomized controlled trial. A total of 158 subjects (79 subjects in each arm) are planned. The control group will receive a traditional cardiac anesthetic using opioids, for which induction will include fentanyl and propofol. The experimental arm will receive an opioid free anesthetic with an induction bolus of dexmedetomidine and propofol. The investigators hypothesize that using the opioid free technique will be more hemodynamically stable within the first 10 minutes of induction.

Conditions

• Opioid Use
• Heart; Surgery, Heart, Functional Disturbance as Result
• Anesthesia

Interventions

Type	Name	Description
DRUG	Opioid Anesthetics	see arm/group description
DRUG	Non Opioid Analgesics	see arm/group description

Timeline

• Start date: 2020-02-04
• Primary completion: 2020-03-14
• Completion: 2020-03-14
• First posted: 2019-12-13
• Last updated: 2020-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study