Dexmedetomidine for Sedation in Total Knee Replacements

NCT02466022 | Completed Phase 3

• 1 other identifier: U of S BIO 15-76
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control, with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine has been used with a large loading dose and infusion, which has been known to cause dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine produces less negative side-effects, but still effective sedation and reduced post-operative pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only a few studies exist investigating its benefits when administered for sedation purposes with spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The investigators hypothesize that single dose dexmedetomidine for procedural sedation will reduce opioid consumption after total knee arthroplasty (TKA).

Conditions

Post-operative Pain for Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total Morphine Consumption

  mg of IV morphine administered via Patient Controlled Analgesia. Patient will be told to deliver morphine dose for pain =\>4 from a numerical rating scale for pain from 0 to 10

  24 Hours

Secondary Outcomes (18)

• Morphine Consumption

  6, 12 and 24 hours, and time to first morphine request

• Pain

  6, 12 and 24 hours

• Intraoperative Midazolam

  During the operation

• Time of readiness of discharge from the post-anesthetic care unit

  Immediately post-operation, average 1 hour

• Intraoperative heartrate

  During the operation

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Patients will receive one 0.5ug/kg bolus of Dexmedetomidine over 10 minutes for sedation prior to spinal anesthetic (12.75mg of heavy Bupivicaine and 10ug of Fentanyl) and 0-4mg of Midazolam for rescue sedation

Drug: Dexmedetomidine; Drug: Bupivicaine; Drug: Normal Saline; Drug: Fentanyl; Drug: Midazolam

Normal Saline

PLACEBO COMPARATOR

Patients will receive 0.1cc/kg Normal Saline bolus delivered over 10 minutes for control arm prior to spinal anesthetic (12.75mg of heavy Bupivicaine and 10ug of Fentanyl) and 0-4mg of Midazolam for rescue sedation

Drug: Bupivicaine; Drug: Normal Saline; Drug: Fentanyl; Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Bolus dose prior to spinal anesthetic

Also known as: Precedex

Dexmedetomidine

Bupivicaine DRUG

Intrathecal hyperbaric bupivicaine 12.75mg

Also known as: Marcaine

Dexmedetomidine; Normal Saline

Normal Saline DRUG

Bolus 0.1cc/kg Normal Saline over 10 min

Also known as: Normosol

Dexmedetomidine; Normal Saline

Fentanyl DRUG

Intrathecal Fentanyl 10ug

Dexmedetomidine; Normal Saline

Midazolam DRUG

0-4mg of IV Midazolam prn for rescue sedation

Also known as: Versed

Dexmedetomidine; Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults over 18 years undergoing elective unilateral primary total knee arthroplasty under spinal anesthesia with an American Society of Anesthesiologists physical status class I to III.

You may not qualify if:

• will include contraindication to:
• Dexmedetomidine,
• morphine, or
• Spinal Anesthesia,
• as well as anybody with chronic pain being treated by opioids prior to the operation.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4S 0A5, Canada

Location

Related Publications (6)

• Abdallah FW, Abrishami A, Brull R. The facilitatory effects of intravenous dexmedetomidine on the duration of spinal anesthesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jul;117(1):271-8. doi: 10.1213/ANE.0b013e318290c566. Epub 2013 Apr 30.

  PMID: 23632057 BACKGROUND

• Jung SH, Lee SK, Lim KJ, Park EY, Kang MH, Lee JM, Lee JJ, Hwang SM, Hong SJ. The effects of single-dose intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia. J Anesth. 2013 Jun;27(3):380-4. doi: 10.1007/s00540-012-1541-0. Epub 2013 Jan 10.

  PMID: 23307164 BACKGROUND

• Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.

  PMID: 20039221 BACKGROUND

• Hong JY, Kim WO, Yoon Y, Choi Y, Kim SH, Kil HK. Effects of intravenous dexmedetomidine on low-dose bupivacaine spinal anaesthesia in elderly patients. Acta Anaesthesiol Scand. 2012 Mar;56(3):382-7. doi: 10.1111/j.1399-6576.2011.02614.x. Epub 2012 Jan 4.

  PMID: 22220945 BACKGROUND

• Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.

  PMID: 23706726 BACKGROUND

• Paul JE, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V. Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013 May;60(5):423-31. doi: 10.1007/s12630-013-9902-1. Epub 2013 Mar 12.

  PMID: 23479393 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Saline Solution; normosol R; Fentanyl; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Piperidines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jurgen Maslany, MD, FRCPC

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

CA (1)