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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Intravenous bolus: between 0.2 and 0.5 mcg/kg. followed by Intravenous infusion: ranging from 0.2 to 0.7 mcg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.
Intravenous bolus: between 0.5 and 1.5 mg/kg. followed by Intravenous infusion: ranging from 0.5 to 2.0 mg/kg/h to the discretion of the attending anesthesiologist. Bolus will be initiated prior to surgical incision and infusion will be stopped at wound closure.
Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain.
CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus)
Québec, Quebec, Canada
RECRUITINGRecruitment rate
Number of patients who are approached to participate by the study team and who consent to participate in the study.
Time frame: 1 week
Proportion of participants receiving dexmedetomidine
Proportion of patients in the dexmedetomidine group who receive per protocol treatment (i.e. they receive dexmedetomidine during general anesthesia).
Time frame: 24 hours
Proportion of participants receiving lidocaine
Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia).
Time frame: 24 hours
Completeness of data collection for outcome measures
Completeness of data collection, defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point for each instrument and participant.
Time frame: 6 months
Sex representativeness of participants
Proportion of female participants enrolled in the trial.
Time frame: 6 months
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