Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The levels of fasciculation
研究概览
简要总结
Succinylcholine is currently the only depolarizing neuromuscular blocker widely used in anesthesia induction and is the drug of choice for rapid sequential anesthesia induction. However, with succinylcholine, varying degrees of muscle fibrillation and muscle pain occur. Intravenous injection of succinylcholine caused by myomuscular fibrillation can cause increased intragastric pressure, intraocular pressure and intracranial pressure, increased serum potassium and postoperative myalgia, increased the incidence of adverse events such as needle prolapse, extravasation of injected drugs, and reduced perioperative comfort of patients. Pretreatment with cisatracurium provides limited prevention of muscular fibrillation due to succinylcholine, but the choice of dose often depends on user experience, and there have been no previous studies of age-related doses of cisatracurium for the prevention of muscular fibrillation caused by succinylcholine, and its half-effective amount (ED50) has not been established. In this study, patients treated with elective general anesthesia surgery were the subjects, and in the process of general anesthesia induction, cis-atracurium was pretreated to evaluate the degree of inhibition of muscular fibrillation caused by succinylcholine, and half of the effective dose of cis-atracurium inhibition of muscular fibrillation caused by succinylcholine was calculated by sequential method.
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
- None
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
- 是
入选标准
- •Ages ranged from 18 to
- •ASA # or # level.
排除标准
- •Allergy or contraindication to cisatracurium or succinylcholine;
- •Associated with cardiovascular disease, diabetes, hyperkalemia, increased intraocular pressure, increased intracranial pressure, gastroesophageal reflux, difficult airway, malignant hyperthermia, neuromuscular disease Sick;
- •Take drugs that may affect neuromuscular function before surgery
- •Liver or kidney failure
- •Pregnancy
研究组 & 干预措施
Age range of 18 to 44 years olds
The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.
干预措施: Cisatracurium (Drug)
Age range of 45 to 59 years olds
The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.
干预措施: Cisatracurium (Drug)
Age range of 60 to 80 years olds
The initial dose of cisatracurium for pre-injection was set at 0.015mg/kg according to previous literature and preliminary test results. The dose of cisatracurium was according to the patients' fasciculation level. If there is no fasciculation (negative reaction), the dose of cisatracurium in the next patient will be reduced until the patient has fasciculation. If there is fasciculation (positive reaction), the dose of cisatracurium will be increased in the next patient until the patient has no fasciculation.
干预措施: Cisatracurium (Drug)
结局指标
主要结局
The levels of fasciculation
时间窗: an average of 2 minutes
Fasciculation after the administration of medications was examined and graded by an anesthesiologist using four-point Likert scale: Grade 0 = no fasciculation; Grade 1 = mild, fine fasciculations of the eyes, neck, face, or fingers, without limb movement; Grade 2 = moderate fasciculations occurring at more than two sites or obvious limb movement; and Grade 3 = vigorous or severe, sustained, and widespread fasciculations in the trunk and limbs.
The appearance of fasciculation Yes or No
时间窗: an average of 2 minutes
Yes or No
次要结局
未报告次要终点
研究者
Zhuan Zhang
Director
Yangzhou University