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Dexmedetomidine has been often used for procedural sedation. It has also has been shown to have a pain sparing effect. Therefore the investigators propose that if Dexmedetomidine is used for sedation in total knee replacements done under spinal anesthetic, the patients will have less pain up to 24 hours after the procedure.
Randomization will occur prior to patient being brought into operating room (by pharmacy or by the anesthesia research coordinator). A third anesthetist not involved in the project will mix up the syringe based on instructions in an opaque envelope, and provide the syringe to the attending anesthetist.
The current standard of care entails patients receiving a midazolam bolus for sedation during the operation. The investigators propose to substitute a syringe of dexmedetomidine or saline to be run as an infusion throughout the case for sedation. A midazolam bolus will be available at anesthetist discretion to achieve a moderate sedation score as defined by the American Society of Anesthesia.
Standardized Medication Protocol
Pre-op:
Tylenol and Naproxen
Spinal:
Marcaine .75%, 1.7cc (12.75mg) Fentanyl 10 micrograms
Sedation
Plan for bolus of 0.5microgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr (Can be titrated from 0.2-0.7 microgram per kg per hr to achieve moderate sedation as defined by the ASA
Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Post op- Initial setting of patient-controlled-analgesia pump to be set at morphine 1 mg, lockout of 8 minutes, to be increased to 1.5 mg with lockout of 6 minutes if pain not controlled. The investigators will increase the pump dose by 0.5 mg/dose/1 hr until pain controlled.
Risks The most common treatment-emergent adverse reactions for dexmedetomidine, occurring in 2% of patients in both ICU and procedural sedation studies, include- Hypotension, Bradycardia and Dry mouth. To minimize the risks to participants, an anesthesiologist will always be present in the room while the infusion is running, will monitor the patient, and will be allowed to treat as they see fit any of these risks.
Data Collection Data collection will be performed primarily by Ian Chan, anesthesiology resident.
Primary Outcome:
Total morphine consumption in the first 24 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine arm | Experimental | Standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision. Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA. |
|
| Saline Placebo | Placebo Comparator | Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed, Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
| ||
| Normal Saline Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption | Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time of First Analgesia Request | time of first analgesia request from closure of skin up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Scores | Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark. | 6, 12 and 24 hour marks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian A Chan, MD | Department of Anesthesia, University of Saskatchewan, Canada | Principal Investigator |
| Jurgen Maslany, MD, FRCPC | University of Saskatchewan | Principal Investigator |
| Kyle Gorman, MD, FRCPC | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina General Hospital | Regina | Saskatchewan | S4P 0W5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26830642 | Derived | Chan IA, Maslany JG, Gorman KJ, O'Brien JM, McKay WP. Dexmedetomidine during total knee arthroplasty performed under spinal anesthesia decreases opioid use: a randomized-controlled trial. Can J Anaesth. 2016 May;63(5):569-76. doi: 10.1007/s12630-016-0597-y. Epub 2016 Jan 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine Arm | Standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision. Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. Dexmedetomidine |
| FG001 | Saline Placebo | Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed, Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. Normal Saline Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine Arm | Standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision. Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA. Dexmedetomidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Consumption | Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3. | Posted | Mean | Standard Deviation | milligrams | 24 hours |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine Arm | Standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision. Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. Dexmedetomidine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian Chan | University of Saskatchewan-Department of Anesthesia | 306-717-8028 | iac549@mail.usask.ca |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| BG001 | Saline Placebo | Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed, Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. Normal Saline Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,
Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.
Normal Saline Placebo
|
|
|
| Secondary | Time of First Analgesia Request | Not Posted | time of first analgesia request from closure of skin up to 24 hours. |
| Other Pre-specified | VAS Scores | Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark. | Not Posted | 6, 12 and 24 hour marks. |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Saline Placebo | Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed, Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. Normal Saline Placebo | 0 | 20 | 0 | 20 |
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