跳至主要内容
临床试验/NCT02186132
NCT02186132已完成4 期

The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia

Mahidol University0 个研究点目标入组 40 人开始时间: 2012年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
主要终点
heart rate

研究概览

简要总结

Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.

Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)

Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure.

The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group.

Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy.

The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status 1-3
  • age = or > 18 years
  • patient receiving neuromuscular blocking agent

排除标准

  • baseline heart rate before administration of the study drugs < 65 bpm
  • history of allergy to the study drugs
  • patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
  • history of complete heart block or second degree AV block.

研究组 & 干预措施

Atropine 0.6 mg

Experimental

Atropine 0.6 mg intravenous

干预措施: Atropine 0.6 mg (Drug)

Atropine 1.2 mg intravenous

Active Comparator

Atropine 1.2 mg intravenous

干预措施: Atropine 1.2 mg (Drug)

结局指标

主要结局

heart rate

时间窗: 24 hours

次要结局

  • bradycardia(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

0.6 vs. 1.2 mg Atropine Together With Neostigmine... | 临床试验