Lidocaine + Dexmedetomidine for Surgery Outcomes

(OPUS Trial)

Overseen by Alexis Turgeon, MD MSc FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CHU de Quebec-Universite Laval

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Manoj M. Lalu, MD PhD FRCPC

Principal Investigator

Ottawa Hospital Research Institute

Dean A. Fergusson, PhD

Principal Investigator

Ottawa Hospital Research Institute

Michael Verret, MD PhD FRCPC

Principal Investigator

CHU de Quebec-Université Laval Research Center

Alexis Turgeon, MD MSc FRCPC

Principal Investigator

CHU de Quebec-Université Laval Research Center

Eligibility Criteria

This trial is for patients undergoing major non-cardiac surgery who may benefit from improved recovery strategies. It aims to test if dexmedetomidine and lidocaine given during general anesthesia can help with postoperative pain and quality of life. Specific eligibility criteria are not provided, but typically include adults in good health without conditions that would interfere with the study or pose risks.

Inclusion Criteria

Able to complete baseline quality of recovery assessment

I will need general anesthesia for my procedure.

I am scheduled for a major surgery that is not heart-related, lasting over 1.5 hours and requires at least one night in the hospital.

Exclusion Criteria

Pregnant women

No fixed address

I am not allergic to dexmedetomidine or lidocaine and do not have severe kidney, liver issues, slow heart rate, or low blood pressure.

Treatment Details

Interventions

• Dexmedetomidine (Alpha-2 Adrenergic Agonist)
• Lidocaine (Local Anesthetic)

Trial Overview The OPUS Anesthesia Pilot Trial is testing whether intravenous dexmedetomidine and lidocaine administered during surgery can improve patient outcomes compared to a control group receiving standard care. The study will assess the feasibility of a larger phase 3 trial on these interventions.

Participant Groups

Group I: Usual care Experimental Treatment 1 Intervention

Group II: Intraoperative intravenous lidocaine Experimental Treatment 1 Intervention

Group III: Intraoperative intravenous dexmedetomidine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

Collaborator

Trials

2

Recruited

840+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

International Anesthesia Research Society (IARS)

Collaborator

Trials

7

Recruited

1,700+