Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Morphine Equivalents Used During the First 48 Hours Post-Surgery
研究概览
简要总结
This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.
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
- Double (Participant, 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 who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
- •Subject is non-lactating and is either:
- •Not of childbearing potential
- •Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
- •Subject is ASA physical status 1, 2, or 3.
排除标准
- •Subject is pregnant or breastfeeding
- •Any subject whom the investigators deem unable to complete any/all research related tasks
- •Subjects who are cognitively impaired (by history)
- •Subject requires antipsychotic medications
- •Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
- •Subject has known allergy to dexmedetomidine
- •Subjects with impaired renal or hepatic function
- •Subjects with advanced heart block
- •Subjects with severe ventricular dysfunction
研究组 & 干预措施
IV dexmedetomidine
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
干预措施: Dexmedetomidine (Drug)
Placebo
saline placebo
干预措施: Placebo Saline (Other)
结局指标
主要结局
Morphine Equivalents Used During the First 48 Hours Post-Surgery
时间窗: Up to 48 Hours Post-Surgery (Day 2)
Amount of morphine administered during the 48 hours following surgery.
次要结局
- Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery(48 Hours Post-Surgery (Day 2))
- Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery(Up to 48 Hours Post-Surgery (Day 2))
- Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery(48 Hours Post-Surgery (Day 2))
- Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery(Week 6)
- Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery(48 Hours Post-Surgery (Day 2))
- Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery(Week 6)
- Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery(Week 6)
- Morphine Equivalents Used at 6 Weeks Post-Surgery(Up to Week 6)
- Length of PACU Stay(From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours))
- Length of Hospital Stay(From admission up to discharge (Up to 6 Weeks))
- Number of Participants Requiring Pressor Use During Intraoperative Period(From beginning up to end of surgery (Day 0 - typically 1 to 3 hours))