Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial

Summary

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

Conditions

• Anesthesia
• Anesthesia Complication
• Surgery
• Quality of Life
• Pain, Postoperative
• Anesthesia Morbidity
• Feasibility Studies
• Patient-centredness

Interventions

DRUG

Dexmedetomidine

Intravenous bolus: between 0.2 and 0.5 mcg/kg. followed by Intravenous infusion: ranging from 0.2 to 0.7 mcg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.

DRUG

lidocaine

Intravenous bolus: between 0.5 and 1.5 mg/kg. followed by Intravenous infusion: ranging from 0.5 to 2.0 mg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.

OTHER

control group

Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain.

Sponsors & Collaborators

• Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

  collaborator UNKNOWN

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• International Anesthesia Research Society (IARS)

  collaborator OTHER

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Michael Verret, MD PhD FRCPC · CHU de Quebec-Université Laval Research Center

• Dean A. Fergusson, PhD · Ottawa Hospital Research Institute

• Manoj M. Lalu, MD PhD FRCPC · Ottawa Hospital Research Institute

• Alexis Turgeon, MD MSc FRCPC · CHU de Quebec-Université Laval Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2027-04-30

Completion

2027-10-31

Countries

• Canada

Study Locations