Can Dexmedetomidine For Procedural Sedation In Knee Arthroplasty Reduce Postoperative Pain? A Randomized Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Morphine Consumption
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Normal Saline Placebo (Drug)
结局指标
主要结局
Morphine Consumption
时间窗: 24 hours
Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.
次要结局
- Time of First Analgesia Request(time of first analgesia request from closure of skin up to 24 hours.)
研究者
Ian Chan
MD
University of Saskatchewan