Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study

NCT02026141 | Completed Phase 4 Results DMC

• 1 other identifier: UofS 13-232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time of First Analgesia Request

  time of first analgesia request from closure of skin up to 24 hours.

Other Outcomes (1)

• VAS Scores

  6, 12 and 24 hour marks.

Study Arms (2)

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.

Drug: Dexmedetomidine

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.

Drug: Normal Saline Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine arm

Normal Saline Placebo DRUG

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.

You may not qualify if:

• Contraindication to Dexmedetomidine. (second or third degree heart block, renal or hepatic dysfunction) Contraindication to Spinal Anesthetic Pain being treated by opioids prior to operation Contraindication to premedication Previous total knee arthroplasty

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Publications (1)

• 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.

  PMID: 26830642 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ian Chan
• Organization: University of Saskatchewan-Department of Anesthesia

iac549@mail.usask.ca

306-717-8028

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 20, 2016
• Results First Posted: June 20, 2016

Record last verified: 2016-05

Locations

CA (1)