Michael Verret, MD, MSc
Université Laval
Québec, Canada
Dr. Verret’s Research
OPUS pilot trial
Abstract: The use of co-analgesia (i.e., opioid minimization strategies) during surgery has been identified as a research priority by multiple public health agencies. Through a scoping review, systematic reviews and surveys of anesthesiologists, dexmedetomidine and lidocaine were identified as the most promising opioid minimization strategies. However, whether these interventions can improve postoperative patient-centred outcomes is unknown. This trial will utilize a multicenter, multi-arm randomized clinical trial (RCT) to evaluate the effectiveness of intraoperative dexmedetomidine and lidocaine on patient-centred outcomes compared to usual care. The aim of this trial is to conduct a pilot RCT (Vanguard phase) to evaluate the feasibility of conducting a pragmatic adaptive multicentre (full) RCT.
The PI will conduct a multicentre pilot RCT in three tertiary academic centres to assess the feasibility of a pragmatic adaptive multicentre RCT. Adult surgical patients having non-cardiac surgery under general anesthesia (<60 years old) will be recruited. Patients will be assigned to one of the 3 arms (usual care, dexmedetomidine, and lidocaine) with an allocation ratio of 1:1:1. The primary outcome for the full RCT will be the quality of recovery (QoR-15). For the OPUS pilot RCT, the recruitment rate will be measured and compliance to protocol and feasibility of outcome will be assessed. To determine feasibility of the planned adaptive component of the full RCT, the feasibility of quickly collecting and reporting data (<48h) will be assessed. Pooled primary and secondary outcomes will be described separately using Wilson’s method to generate proportion of patients recruited, clinician compliance with the intervention, and completion of the QoR-15 questionnaire with 95% confidence intervals. Patients enrolled in the pilot phase will be rolled in the full trial. The OPUS pilot RCT will serve as a foundation for informing a pragmatic adaptive multicentre RCT on opioid minimization strategies.
International Anesthesia Research Society