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

Laval University

Status: Enrolling

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

Treatments: Drug: lidocaine; Other: control group; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06884540

OMS-162

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Intraoperative intravenous dexmedetomidine

Experimental group

Treatment:

Drug: Dexmedetomidine

Intraoperative intravenous lidocaine

Experimental group

Treatment:

Drug: lidocaine

Usual care

Other group

Treatment:

Other: control group