Antagonism of Neostigmine in Continuous Infusion of Mivacurium: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The time from count 2 to TOFr recovery to 0.9
研究概览
简要总结
In this study, the antagonism of neostigmine, a cholinesterase inhibitor, on continuous infusion of mivacurium during foot and ankle surgery under general anesthesia was investigated, and the appropriate time point of antagonism was explored.
详细描述
Mivacurium is currently the shortest-acting benzylisoquinoline nondepolarizing muscular relaxant in clinical practice, which is suitable for short surgery. Its continuous infusion can also be used in medium-term surgery with uncertain operation time, which can accelerate the recovery of postoperative muscle relaxation. Whether continuous infusion of mivacurium requires antagonism and the appropriate time point of antagonism is controversial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years old;
- •American Society of Anesthesiologists (ASA) physical stastus classification system: I-II;
- •Body mass index (BMI) 18.5 - 30 kg/m2
- •Patients with normal cholinesterase levels before the operation
排除标准
- •Refusal to participate in the study;
- •ASA classification of grade III or above;
- •Severe organ dysfunction, difficult airway or neurological muscle disorders;
- •Taking drugs that affect neuromuscular monitoring or neuromuscular conduction function;
- •Allergic to the test drug or having other contraindications;
- •Pregnant and lactating women
研究组 & 干预措施
Non-antagonistic group
No intervention
Train of four stimulation ratio (TOFr) 0.4 antagonist group
When TOFr is 0.4, administer neostigmine.
干预措施: Neostigmine (Drug)
Count-2 antagonist group
When relaxation monitoring is count 2, administer neostigmine.
干预措施: Neostigmine (Drug)
结局指标
主要结局
The time from count 2 to TOFr recovery to 0.9
时间窗: Perioperative
次要结局
- Heart rate(Perioperative)
- Surgical duration(The start time and end time of the surgery)
- The time from count 2 to TOFr recovery to 0.7(Perioperative)
- The time from count 2 to TOFr recovery to 0.4(Perioperative)
- Mean Arterial Pressure(Perioperative)
- Blood pressure(Perioperative)