Do Small Doses of Atropine Cause Bradycardia in Young Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Bradycardia
研究概览
简要总结
An infants heart rate is very important because it ensures that blood is pumped to all organs in the body. Heart rate may decrease during anesthesia and surgery, and this is why the anesthesiologist will often give a medication to prevent this from happening. The most common drug for this purpose is called atropine. The dose of most drugs given to babies is based upon the baby's weight, but some believe that the dose of atropine should not be less than 0.1mg. However there is no evidence to support this minimum dose. A larger dose of atropine may cause a very fast heart rate instead. Anesthesiologists routinely dose the atropine based upon the baby's weight without regard for a minimum dose.
The purpose of the present study is to measure the heart rate after doses of atropine in neonates and infants who receive less than 0.1 mg.
详细描述
60 infants, ASA physical status I and II, undergoing elective surgical procedures will be enrolled after signed informed parental consent.
All children will be fasted according to institutional guidelines and unpremedicated. After arriving in the operating room, EKG, pulse oximeter and blood pressure monitors will be applied (Datex-Ohmeda Aisys).
Anesthesia will be induced with 66% N2O in O2 and 8% sevoflurane. Respiration will be supported by a properly sized face mask through which he/she is allowed to breath spontaneously. Respiration will continue spontaneously through a facemask at 2 MAC sevoflurane in 66% N2O.
All children will be positioned supine, warmed with a forced air warmer and given 20 ml/kg IV balanced salt solution over 30 minutes after the IV has been established. The end-tidal pCO2 will maintained 35-45 mmHg and oxygen saturation >96%.
After a 22 or 24G IV cannula is inserted, 0.005 mg/kg atropine will be administered intravenously over 5 seconds through a fast-flowing IV and followed by 5 ml of normal saline to flush it in through the IV deadspace. The study (ECG recording) period will extend from 30 seconds before atropine administration to 5 minutes after injection. During this time the heart rate and rhythm (through lead II) will be monitored and recorded continuously using an analogue interface system. EKG will be recorded on paper continuously for the 330 seconds of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Observer of ECG rhythm strips was unaware of the study hypothesis, the study drug administered, the dose given and the arrhythmias sought. Your statement that masking a single outcome implies a multi-arm study precludes a panoramic perspective of clinical research study designs and scenarios in which assessors may be effectively blinded.
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 0-2 years old
- •Weight : less than the 95th percentile for age and height ( no more than 15kg )
- •ASA classification : I-II
- •Meets the hospital and department of anesthesiology guidelines with respect to peri-operative care
排除标准
- •History of heart disease
- •Any condition predisposing to arrhythmia
- •Any medication known to influence the heart rate
- •Child taking anti-cholinergic medication routinely
- •The use of succinylcholine anticipated (will cause bradycardia)
- •Rapid sequence intubation is required (due to aspiration risk)
- •Known difficult airway (may be difficult to bag mask ventilate)
研究组 & 干预措施
Infants and children less than 15Kg.
This group consists of children who are ASA physical status I and II, less than 2 years of age and scheduled for elective surgical procedure and weigh less than 15Kg will receive atropine 5 mcg/kg IV during sevoflurane anesthesia.
干预措施: Atropine (Drug)
结局指标
主要结局
Incidence of Bradycardia
时间窗: five minutes
incidence of bradycardia or other arrhythmias
次要结局
未报告次要终点
研究者
Jerrold Lerman
Clinical Professor of Anesthesiology
State University of New York at Buffalo