Effect of Calcium Chloride on Recovery From Neuromuscular Blockade in Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time to train of-four ratio of 0.9.
研究概览
简要总结
The purpose of this study is to evaluate the effect of calcium chloride against residual neuromuscular blockade at the end of general anesthesia
详细描述
During general anesthesia, neuromuscular blocking agent is administered to facilitate endotracheal intubation and the view of operative field. The neuromuscular blockade should be reversed at the end of anesthesia to recover spontaneous breathing of the patient.
Residual neuromuscular blockade (RNMB) is defined as train of-four ratio < 0.9. RNMB is a risk factor for postoperative pulmonary complication and increases postoperative mortality. Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.
Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium chloride on residual neuromuscular blockade is not studied yet.
The purpose of this study is to evaluate the effect of calcium chloride on residual neuromuscular blockade at the end of general anesthesia
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
- Triple (Participant, Investigator, 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
- •Body mass index 15.0-25.0 kg/m2
- •American Society of Anesthesiologists physical status I-III
- •Scheduled for elective surgery with an expected duration of more than 60 min under general anesthesia with endotracheal intubation
排除标准
- •Suspected difficulty airway
- •Bronchial asthma, chronic obstructive pulmonary disease
- •Neuromuscular disease
- •Hepatic or renal dysfunction.
- •Taking medications that might influence the effect of neuromuscular blocking agents
- •Allergy to the medication that used in this trial
- •Pregnant, or breastfeeding state
- •Suspected malignant hyperthermia
- •Contraindication to the medication that used in this trial
- •Hypercalcemia
研究组 & 干预措施
Calcium
Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
干预措施: Calcium (Drug)
control
In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
干预措施: control (Drug)
结局指标
主要结局
Time to train of-four ratio of 0.9.
时间窗: At 10 minutes (expected aeverage) after the surgery
Train of-four will be measured using acceleromyograph.
次要结局
- Train of-four ratio(At 5, 10, 20 minutes after the administration of reversal drug)
- Length of PACU stay(At 60 minutes (expected average) after the surgery)
研究者
Deok Man Hong
Associate Professor
Seoul National University Hospital