Clinical trial NCT06884540: Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial
Official title: Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
name: Canadian Institutes of Health Research (CIHR)
name: International Anesthesia Research Society (IARS)
First posted: 2025-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of participants receiving dexmedetomidine
timeFrame: 24 hours
measure: Proportion of participants receiving lidocaine
timeFrame: 24 hours
measure: Completeness of data collection for outcome measures
timeFrame: 6 months
measure: Sex representativeness of participants
timeFrame: 6 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)
state: Quebec
Study officials:
affiliation: CHU de Quebec-Université Laval Research Center
name: Michael Verret, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Dean A. Fergusson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Manoj M. Lalu, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Quebec-Université Laval Research Center
name: Alexis Turgeon, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: