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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02026141
Enrollment
40
Registered
2014-01-01
Start date
2013-12-31
Completion date
2014-06-30
Last updated
2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

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.

Detailed description

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 1. st arm- Dexmedetomidine, drawn up into a 50cc syringe of saline, thereby making it 5ug/ml. 2. 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

Interventions

DRUGDexmedetomidine
DRUGNormal Saline Placebo

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine Consumption24 hoursPatients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.

Secondary

MeasureTime frame
Time of First Analgesia Requesttime of first analgesia request from closure of skin up to 24 hours.

Other

MeasureTime frameDescription
VAS Scores6, 12 and 24 hour marks.Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.

Countries

Canada

Participant flow

Participants by arm

ArmCount
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. Dexmedetomidine
20
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. Normal Saline Placebo
20
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation01

Baseline characteristics

CharacteristicSaline PlaceboDexmedetomidine ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants11 Participants20 Participants
Age, Categorical
Between 18 and 65 years
11 Participants9 Participants20 Participants
Age, Continuous66.1 years
STANDARD_DEVIATION 8.2
66.2 years
STANDARD_DEVIATION 11.4
66.2 years
STANDARD_DEVIATION 9.2
Region of Enrollment
Canada
20 participants20 participants40 participants
Sex: Female, Male
Female
12 Participants16 Participants28 Participants
Sex: Female, Male
Male
8 Participants4 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Morphine Consumption

Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Dexmedetomidine ArmMorphine Consumption29.2 milligramsStandard Deviation 11.2
Saline PlaceboMorphine Consumption61.2 milligramsStandard Deviation 17.2
p-value: <0.05ANCOVA
Secondary

Time of First Analgesia Request

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

Other Pre-specified

VAS Scores

Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.

Time frame: 6, 12 and 24 hour marks.

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026