Anesthesia, Anesthesia Complication, Anesthesia Morbidity, Feasibility Studies, Pain, Postoperative, Patient-centredness, Quality of Life, Surgery
Conditions
Keywords
Pilot trial, Anesthesia, Quality of recovery, Postoperative pain, Opioid minimization strategies, Dexmedetomidine, Lidocaine, Patient-centred outcomes
Brief summary
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.
Interventions
DRUGDexmedetomidine
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.
DRUGlidocaine
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.
OTHERcontrol group
Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain.
Sponsors
CHU de Quebec-Universite Laval
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
Canadian Institutes of Health Research (CIHR)
International Anesthesia Research Society (IARS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Neurosurgical procedures except for spine surgery. 6. Planned postoperative intubation after PACU discharge. 7. No fixed address.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 week | Number of patients who are approached to participate by the study team and who consent to participate in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants receiving dexmedetomidine | 24 hours | Proportion of patients in the dexmedetomidine group who receive per protocol treatment (i.e. they receive dexmedetomidine during general anesthesia). |
| Proportion of participants receiving lidocaine | 24 hours | Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia). |
| Completeness of data collection for outcome measures | 6 months | 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. |
| Sex representativeness of participants | 6 months | Proportion of female participants enrolled in the trial. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMichael Verret, MD PhD FRCPC
CHU de Quebec-Université Laval Research Center
PRINCIPAL_INVESTIGATORDean A. Fergusson, PhD
Ottawa Hospital Research Institute
PRINCIPAL_INVESTIGATORManoj M. Lalu, MD PhD FRCPC
Ottawa Hospital Research Institute
PRINCIPAL_INVESTIGATORAlexis Turgeon, MD MSc FRCPC
CHU de Quebec-Université Laval Research Center
Outcome results
None listed