The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Overall Benefit of Analgesia Score (OBAS)
研究概览
简要总结
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 80 years of age (inclusive)
- •Presenting to the study hospital for lumbar decompression and/or fusion (instrumented fusion of the lumbar spine < 4 levels) under general anesthesia, and scheduled for same-day admission or in-patient admission
- •American Society of Anesthesiologists (ASA) Category 1, 2 or 3
排除标准
- •Known allergy to Dantrolene, morphine or other opioids, benzodiazepines that causes a reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters, irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness, drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or nephritis
- •Oxygen saturation < 94%
- •Patient being treated with any of the following medications:Non-dihydropyridine Calcium Channel Blockers including verapamil, Estrogen therapy
- •Current or past medical history of any of the following: hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic hypoxia or hypercapnia, COPD)
- •Recent history of aspiration (within the last 3 months)
- •Patients with any history of neuromuscular dysfunction
- •History of obstructive sleep apnea
- •Weight > 140 kg
- •Currently pregnant
- •Actively breastfeeding
- •Inability to provide written informed consent
研究组 & 干预措施
Placebo Oral Tablet Group
Patients will receive a 25 mg of a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
干预措施: Placebo Oral Tablet (Drug)
Dantrolene Group
Patients will receive 25 mg of Dantrolene orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
干预措施: Dantrolene (Drug)
结局指标
主要结局
Overall Benefit of Analgesia Score (OBAS)
时间窗: Measured at 24 hours after surgery
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
次要结局
- Numerical Rating Scale (NRS) for Pain(Measured at 0, 1, 2, 3, 24, 48 hours after surgery)
- ICU Length of Stay(Until discharge from the hospital, on average 24 hours)
- Benzodiazepine use postoperatively(Until discharge from the hospital, on average three days)
- Hospital length of stay(Until discharge from the hospital, on average three days)
- Morphine Equivalent Dose(Duration of the patient's stay in the hospital, on average three days)
- Richmond Agitation Sedation Scale (RASS)(Measured at 24 and 48 hours after surgery)
- Overall Benefit of Analgesia Score (OBAS)(Measured at 48 hours after surgery)
- ICU Mobility Score(Measured at 24 and 48 hours after surgery)
研究者
Richard J. Pollard
Director, Neurosurgical Anesthesia Fellowship
Beth Israel Deaconess Medical Center