Prospective randomized controlled trial for comparison of effect on neuromuscular blockade recovery between calcium gluconate coadministered with neostigmine and neostigmine only in pediatric patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration between injecting reversal agent and TOFr more than 90%
研究概览
简要总结
Muscle relaxation is theintegral part of general anaesthesia for intubation in elective surgeries. Few studies are published regarding the roleof using calcium with reversal agents for faster recovery in adults only but thereis paucity of studies in pediatric group. After ethical clearance the plan isto compare the effects of addition of calcium gluconate to the reversal agenton the basis of train of four and BIS monitoring.. Using BIS monitoring for thedepth of anaesthesia will be useful to avoid the bias due to the depth ofanaesthesia.
After completion of surgery, as TOFc-4 (Trainof Four count) is achieved, patients will receive 70 µg/kg neostigmine and20µg/kg glycopyrrolate. Calcium gluconate 5mg/kg will be given with neostigmineand glycopyrrolate in the calcium group and normal saline in the control group.Duration of recovery between giving the reversal agent and the train of fourratio of 90 will be noticed and then compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between age of 3 to 15 years 2.ASA I and II.
排除标准
- •1.Suspected difficult airway
- •History of bronchial asthma, neuromuscular disease, hepatic or renal disease.
- •Clinically suspected hypercalcemia
- •Severe or significant congenital heart disease 5.Bleeding diathesis 6.History of allergies to glycopyrrolate or neostigmine 7.Parental refusal
- •Weight of less than 10 kg.
结局指标
主要结局
Duration between injecting reversal agent and TOFr more than 90%
时间窗: 3,5 and 10 min
次要结局
- Post operative Recurarisation at 3,5 and 10 min interval of giving the reversal agent(3,5 and 10 min)