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NCT Number: NCT06884540

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anesthesia Anesthesia Complication Anesthesia Morbidity Feasibility Studies Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient-centredness Postoperative Complications Quality of Life Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital, New Westminster, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Neurosurgical procedures except for spine surgery.
  • Planned postoperative intubation after PACU discharge.
  • No fixed address.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 1 week

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

Secondary outcomes

  1. Proportion of participants receiving dexmedetomidine

    Time frame: 24 hours

    Proportion of patients in the dexmedetomidine group who receive per protocol treatment (i.e. they receive dexmedetomidine during general anesthesia).

  2. Proportion of participants receiving lidocaine

    Time frame: 24 hours

    Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia).

  3. Completeness of data collection for outcome measures

    Time frame: 6 months

    Completeness of data collection, defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point for each instrument and participant.

  4. Sex representativeness of participants

    Time frame: 6 months

    Proportion of female participants enrolled in the trial.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
  • International Anesthesia Research Society (IARS)

Registry information

Official study title

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial

Acronym: OPUS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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