Actively Recruiting
Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies (OPUS) Anesthesia: a Pilot Randomised Controlled Trial
Led by CHU de Quebec-Universite Laval · Updated on 2026-05-27
100
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
CHU de Quebec-Universite Laval
Lead Sponsor
C
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of two drugs, dexmedetomidine and lidocaine, given during major non-cardiac surgery under general anesthesia. This pilot trial aims to see if it is possible to carry out a larger phase 3 study to evaluate how these drugs might improve patient-centered outcomes and recovery after surgery. The study focuses on patients undergoing planned major surgeries lasting at least 1.5 hours with an anticipated hospital stay of one or more nights. Participants may receive intravenous dexmedetomidine or lidocaine starting with a bolus dose before the surgical incision, followed by a continuous infusion until wound closure. There is also a control group receiving usual care where dexmedetomidine is not allowed and lidocaine is only used to prevent or treat pain from propofol injection. Dosing will be adjusted at the attending anesthesiologist's discretion. During the study, patients will be assessed for recruitment feasibility, proportion receiving each drug within 24 hours, and data completeness over six months. Baseline quality of recovery assessments will be completed before surgery, and patient outcomes related to anesthesia, postoperative pain, and quality of life will be monitored. The total duration of participation includes immediate perioperative care and follow-up over six months to assess recovery and safety.
CONDITIONS
Brief Title
Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Undergoing elective major non-cardiac surgery lasting at least 1.5 hours
- Anticipated hospital stay of one or more nights
- Requiring general anesthesia
- Able to complete baseline quality of recovery assessment
You will not qualify if you...
- Known allergies or contraindications to dexmedetomidine or lidocaine (e.g., allergy to alpha-2 agonists or local anesthetics, severe kidney or liver failure, slow heart rate, low blood pressure)
- Regular use of alpha-2 agonists or local anesthetics before hospitalization
- Pregnant women
- Planned use of regional analgesia such as epidural or nerve blocks along with general anesthesia
- Neurosurgery procedures except spine surgery
- Planned postoperative intubation after recovery room discharge
- No fixed home address
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery (lasting at least 1.5 hours)
Participants receive intraoperative intravenous dexmedetomidine or lidocaine, or usual care without dexmedetomidine. The drug infusion starts before surgical incision and stops at wound closure.
1 surgical visit
Duration - Up to 6 months
Participants are monitored for outcomes including drug receipt and quality of recovery over 24 hours to 6 months after surgery.
Multiple follow-up visits up to 6 months
Trial Site Locations
Total: 3 locations
1
CISSS de Chaudière-Appalaches (Hôtel-Dieu de Lévis)
Lévis, Quebec, Canada, G6V3Z1
Actively Recruiting
2
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
3
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
Research Team
S
Sophie Guay, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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