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

NCT06884540 | Recruiting DMC

• 1 other identifier: OMS-162
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pilot trial; Anesthesia; Quality of recovery; Postoperative pain; Opioid minimization strategies; Dexmedetomidine; Lidocaine; Patient-centred outcomes

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  Number of patients who are approached to participate by the study team and who consent to participate in the study.

  1 week

Secondary Outcomes (4)

• Proportion of participants receiving dexmedetomidine

  24 hours

• Proportion of participants receiving lidocaine

  24 hours

• Completeness of data collection for outcome measures

  6 months

• Sex representativeness of participants

  6 months

Study Arms (3)

Intraoperative intravenous dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Intraoperative intravenous lidocaine

EXPERIMENTAL

Drug: lidocaine

Usual care

OTHER

Other: control group

Interventions

Dexmedetomidine DRUG

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.

Intraoperative intravenous dexmedetomidine

lidocaine DRUG

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.

Intraoperative intravenous lidocaine

control group OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>/= 18 years.
• Having elective major non-cardiac surgery (i.e., planned duration \>/= 1.5 hours and anticipated \>/= 1 night hospital stay).
• Requiring general anesthesia.
• Able to complete baseline quality of recovery assessment.

You may not qualify if:

• Individuals with known contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe renal or hepatic failure, bradycardia or hypotension), as per routine assessment.
• Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
• Pregnant women.
• Planned use of regional analgesia (i.e., epidural, peripheral nerve block, trunk nerve block) in conjunction with general anesthesia. Local anesthetics such as lidocaine are administered as part of regional analgesia technique. Combination with intravenous lidocaine is contraindicated to avoid exceeding therapeutic concentration.
• Planned postoperative intubation after PACU discharge.
• No fixed address.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Perioperative Anesthesia Clinical Trials (PACT) Group: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• International Anesthesia Research Society (IARS): collaborator

Study Sites (1)

CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Lidocaine; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michael Verret, MD PhD FRCPC

  CHU de Quebec-Université Laval Research Center

  PRINCIPAL INVESTIGATOR

• Dean A. Fergusson, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Manoj M. Lalu, MD PhD FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Alexis Turgeon, MD MSc FRCPC

  CHU de Quebec-Université Laval Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Guay, MSc

CONTACT

418-525-4444; sophie.guay@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)