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| Name | Class |
|---|---|
| Canadian Perioperative Anesthesia Clinical Trials (PACT) Group | UNKNOWN |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| International Anesthesia Research Society (IARS) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative intravenous dexmedetomidine | Experimental |
| |
| Intraoperative intravenous lidocaine | Experimental |
| |
| Usual care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of patients who are approached to participate by the study team and who consent to participate in the study. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Proportion of participants receiving lidocaine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Verret, MD PhD FRCPC | CHU de Quebec-Université Laval Research Center | Principal Investigator |
| Dean A. Fergusson, PhD | Ottawa Hospital Research Institute | Principal Investigator |
| Manoj M. Lalu, MD PhD FRCPC | Ottawa Hospital Research Institute | Principal Investigator |
| Alexis Turgeon, MD MSc FRCPC | CHU de Quebec-Université Laval Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 0A2 | Canada | ||
| Mount Sinai Hospital |
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|
| lidocaine | Drug | 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. |
|
| control group | Other | Usual care where systemic dexmedetomidine is not allowed and systemic lidocaine is permitted only for the prevention or treatment of propofol injection pain. |
|
Proportion of patients in the lidocaine group who receive per protocol treatment (i.e. they receive lidocaine during general anesthesia). |
| 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. | 6 months |
| Sex representativeness of participants | Proportion of female participants enrolled in the trial. | 6 months |
| Toronto |
| Ontario |
| M5G 1X5 |
| Canada |
| CISSS de Chaudière-Appalaches (Hôtel-Dieu de Lévis) | Lévis | Quebec | G6V3Z1 | Canada |
| Centre hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2X 0C1 | Canada |
| CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus) | Québec | Quebec | G1J 1Z4 | Canada |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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