Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study
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|ClinicalTrials.gov Identifier: NCT02026141|
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Drug: Dexmedetomidine Drug: Normal Saline Placebo||Phase 4|
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
Tylenol and Naproxen
Marcaine .75%, 1.7cc (12.75mg) Fentanyl 10 micrograms
- st arm- Dexmedetomidine, drawn up into a 50cc syringe of saline, thereby making it 5ug/ml.
- nd arm- Receives Normal Saline syringe
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.
Total morphine consumption in the first 24 hours
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: 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.
Placebo Comparator: 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.
Drug: Normal Saline Placebo
- Morphine Consumption [ Time Frame: 24 hours ]Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.
- Time of First Analgesia Request [ Time Frame: time of first analgesia request from closure of skin up to 24 hours. ]
- VAS Scores [ Time Frame: 6, 12 and 24 hour marks. ]Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026141
|Regina General Hospital|
|Regina, Saskatchewan, Canada, S4P 0W5|
|Principal Investigator:||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|