Opioid-minimizing anesthesia with dexmedetomidine or lidocaine to improve recovery after major surgery

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

This pilot will test whether giving intravenous dexmedetomidine or lidocaine during general anesthesia helps adults having major non-cardiac surgery recover better and need fewer opioids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CHU de Quebec-Universite Laval (Academic / other)
• Locations: 1 site (Québec, Quebec)
• Trial ID: NCT06884540 on ClinicalTrials.gov

What this trial studies

This pilot interventional trial compares intravenous dexmedetomidine, intravenous lidocaine, and usual care given during general anesthesia for adults undergoing elective major non-cardiac surgery. The main goal is to determine feasibility for a larger pragmatic adaptive multicentre phase 3 trial by measuring recruitment, protocol adherence, safety, and outcome data collection. Patient-centred outcomes include quality of recovery, postoperative pain, and opioid consumption during the early postoperative period. Findings will inform whether these intraoperative opioid-minimization strategies warrant broader testing and implementation.

Who should consider this trial

Good fit: Adults aged 18 or older scheduled for elective major non-cardiac surgery lasting at least 1.5 hours with an anticipated overnight stay who will receive general anesthesia and can complete baseline recovery assessments are ideal candidates.

Not a fit: Patients with contraindications to dexmedetomidine or lidocaine, those regularly using similar drugs, pregnant women, or those planned for regional anesthesia or postoperative intubation are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, these intraoperative medications could reduce postoperative pain and opioid use and improve patients' speed and quality of recovery after major surgery.

How similar studies have performed: Smaller randomized and observational studies have suggested that intravenous lidocaine and dexmedetomidine can reduce opioid needs and improve recovery metrics, but findings are mixed and not yet confirmed in large pragmatic trials.

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.

Where this trial is running

Québec, Quebec

• CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus) — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Michael Verret, MD PhD FRCPC — CHU de Quebec-Université Laval Research Center
• Study coordinator: Sophie Guay, MSc

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