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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intraoperative intravenous dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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 lidocaine

Group Type EXPERIMENTAL

lidocaine

Intervention Type 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.

Usual care

Group Type OTHER

control group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Regular use of alpha-2 agonists or local anesthetics prior to hospitalization.
3. Pregnant women.
4. 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.
5. Planned postoperative intubation after PACU discharge.
6. No fixed address.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No