Skip to main content
OpenTrials
Completed

NCT Number: NCT02026141

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

About this study

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

  • 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.

Primary Outcome:

Total morphine consumption in the first 24 hours

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

Normal Saline Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time of First Analgesia Request

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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2014
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.