2023-505969-80-00已完成2 期
Intraoperative clonidine for postoperative pain management in patients undergoing spine surgery: a prospective, randomized, blinded, placebo-controlled trial
Aarhus Universitetshospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年8月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU
研究概览
简要总结
To examine analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing elective spine surgery on postoperative opioid consumption
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for degenerative spine surgery at Aarhus University Hospital will be included in the study.
排除标准
- •Age < 18 years
- •Pregnancy and/or lactation
- •Planned treatment with epidural analgesia, methadone, or infusion of ketamine in the perioperative period
- •American Society of Anesthesiologists (ASA) physical status IV or V
- •Allergy to clonidine
- •Inability to provide informed consent
- •Known severe renal insufficiency (eGFR < 30)
- •Known severe bradyarrhythmia
- •Known severe ischemic heart disease
- •Known severe congestive heart failure (Ejection Fraction < 30%)
- •Known severe disseminated cancer disease
结局指标
主要结局
The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU
The primary outcome is postoperative opioid consumption within the first 3 hours after arrival at the PACU
次要结局
- Postoperative opioid consumption within the first 6 hours after arrival at the PACU
- Daily opioid consumption after 1 month
- Intensity of pain at rest and during coughing at 0, 30, 60, 90 and 120 minutes after arrival at the PACU, measured on a Numeric Rating Scale (NRS, 0-10)
- Sedation at 0, 60, and 120 minutes after arrival at the PACU (Ramsey Sedation Score 1-6)
- Nausea and/or vomiting at 0, 60, and 120 minutes after arrival at the PACU (yes/no)
- Time for discharge from the PACU
- Length of hospital stay
研究者
Lone Nikolajsen
Scientific
Aarhus Universitetshospital
研究点 (1)
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