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Dexmedetomidine for Sedation in Total Knee Replacements

NCT02466022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-06-15

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

Bolus dose prior to spinal anesthetic

DRUG

Bupivicaine

Intrathecal hyperbaric bupivicaine 12.75mg

DRUG

Normal Saline

Bolus 0.1cc/kg Normal Saline over 10 min

DRUG

Fentanyl

Intrathecal Fentanyl 10ug

DRUG

Midazolam

0-4mg of IV Midazolam prn for rescue sedation

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Jurgen Maslany, MD, FRCPC · University of Regina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466022 on ClinicalTrials.gov