Does Single Dose Dexmedetomidine for Procedural Sedation Reduce Post-operative Pain in Total Knee Arthroplasty? A Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Total Morphine Consumption
研究概览
简要总结
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).
详细描述
The investigators plan a randomized control trial.
Sample. Based on a literature and a previous study by the investigators team (RQHR #13-80/USask Bio #13-232), average reduction in opioid consumption for dexmedetomidine bolus and infusion is 50%. Less data exists for single dose. However two randomized control trials (Kaya et al., 2010; Hong et al., 2012) reduced consumption frequency by 55% and 45%, using 0.5ug/kg and 1.0ug/kg respectively. A meta-analysis demonstrated a mean difference of -10mg vs -21mg in opioid consumption for bolus studies vs bolus and infusion studies at 24 hours (Schnabel et. al 2013). A reduction of 50% was recently seen in a study conducted earlier by the investigators center at 24hours with a bolus and infusion (RQHR #13-80/USask Bio #13-232). An expected Patient Controlled Analgesia (PCA) consumption at 24hours for total knee arthroplasty is 27mg with a standard deviation of 19mg (Paul et. al, 2013). Using this information, it was decided 40% reduction in opioid consumption at 24hours could be expected and represent a clinically significant result. Subsequent power calculation required a sample size of 50 (25 per arm) to demonstrate a 40% reduction in opioid consumption at 24 hours, with a study power of 80% and P-value under 0.05.
Ethics. Ethics approval was obtained from the University of Saskatchewan Biomedical Research Ethics Board, and from the Regina Qu'Appelle Health Region Research Ethics Board.
Patients will be identified by one of the investigators through the daily surgical slate to which they already have access for patient care.
Informed written consent will be obtained from 50 patients on the Same-Day Admission Unit by one of the investigators not involved in the patient's care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •will include contraindication to:
- •Dexmedetomidine,
- •morphine, or
- •Spinal Anesthesia,
- •as well as anybody with chronic pain being treated by opioids prior to the operation.
研究组 & 干预措施
Dexmedetomidine
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
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
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
干预措施: Bupivicaine (Drug)
Dexmedetomidine
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
干预措施: Normal Saline (Drug)
Dexmedetomidine
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
干预措施: Fentanyl (Drug)
Dexmedetomidine
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
干预措施: Midazolam (Drug)
Normal Saline
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
干预措施: Bupivicaine (Drug)
Normal Saline
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
干预措施: Normal Saline (Drug)
Normal Saline
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
干预措施: Fentanyl (Drug)
Normal Saline
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
干预措施: Midazolam (Drug)
结局指标
主要结局
Total Morphine Consumption
时间窗: 24 Hours
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
次要结局
- Adverse opioid effects of nausea(First 24 hours post-operation)
- Intraoperative blood pressure(During the operation)
- Post-operative heartrate(Immediately after operation in PACU recovery, average 1 hour)
- Pain(6, 12 and 24 hours)
- Intraoperative Midazolam(During the operation)
- Duration of sensory blockade two-dermatome sensory regression(During the operation, and immediately post-operation, average 1 hour)
- Satisfaction(First 24 hours)
- Time to first morphine request(first 24 hours post-operation)
- Adverse opioid effect of vomiting(First 24 hours post-operation)
- Post-operative blood pressure(Immediately after operation in PACU recovery, average 1 hour)
- Duration of Motor blockade(During the operation, and immediately post-operation, average 1 hour)
- Adverse anesthetic effect of shivering(Immediately after operation in PACU recovery, average 1 hour)
- Morphine Consumption(6, 12 and 24 hours, and time to first morphine request)
- Time of readiness of discharge from the post-anesthetic care unit(Immediately post-operation, average 1 hour)
- Intraoperative heartrate(During the operation)
- Adverse opioid effect of constipation(First 24 hours post-operation)
- Adverse opioid effect of urinary retention(First 24 hours post-operation)
- Adverse opioid effect of pruritus(First 24 hours post-operation)
研究者
Nirupan Vipulanathan
Anesthesiology Resident
University of Saskatchewan