NCT05548465已完成不适用
The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative numerical rating scales (NRS) at rest.
研究概览
简要总结
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.
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, Outcomes Assessor)
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
- •Patients undergoing anterior cervical surgery., sign the "informed consent form"
- •Age above 18 years old
排除标准
- •Pregnant or lactating women.
- •Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
- •Allergic to the materials or drugs used in this study.
- •Patients with current/previous gastrointestinal bleeding and gastric ulcers;
- •Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
- •Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.
研究组 & 干预措施
Long-term-opioid-free anesthesia group.
Experimental
干预措施: Remifentanil Hydrochloride (Drug)
Long-term-opioid anesthesia group.
Active Comparator
干预措施: Sufentanil Citrate (Drug)
结局指标
主要结局
Postoperative numerical rating scales (NRS) at rest.
时间窗: Up to 48 hours after operation.
Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.
次要结局
- Postoperative NRS on movement.(Up to 48 hours after operation.)
- Postoperative complications.(Up to 30 days after operation.)
- Postoperative recovery of cervical spine function(Up to 48 hours after operation.)
- Length of stay (LOS) in hospital(Up to 30 days after operation.)
- Total in-hospital cost.(Up to 30 days after operation.)
- Incidence of intraoperative adverse events.(Intraoperative .)
- Postoperative LOS(Up to 30 days after operation.)
- Analgesic medication use before discharge。(Up to 48 hours after operation.)
- Incidence of post operative nausea and vomiting (PONV).(Up to 30 days after operation.)
研究者
研究点 (1)
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