Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- the maximum increase ratio of HR
研究概览
简要总结
Glycopyrrolate is an anticholinergic medication commonly used in respiratory medicine for treating chronic obstructive pulmonary disease (COPD), bronchial asthma, and other conditions . In the perioperative period, it is often administered before anesthesia to reduce secretions in the salivary glands, bronchi, and pharynx . It is used during the recovery period to counteract the muscarinic effects of anticholinesterase inhibitors and can also be employed to prevent/treat vagal reflexes and related arrhythmias induced by surgery or medications .
Heart rate (HR) is influenced by both the sympathetic and parasympathetic nervous systems. The baseline HR of different patients may vary due to differing levels of sympathetic and parasympathetic nerve activity within the body. It remains unclear whether patients with different baseline HRs exhibit varying degrees of HR elevation after the administration of glycopyrrolate(i.e.,the parasympathetic activity in vivo is antagonized). The primary aim of this study is to explore the impact of glycopyrrolate administration on HR in patients with different baseline HRs. The secondary objective is to investigate the effects of glycopyrrolate on heart rate variability (HRV) in patients with different baseline HR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •1.Weight not restricted; 2.American Society of Anesthesiologists (ASA) status I or II; 3.The operative time≥1 h; 4.Undergoing orthopedic or urological surgery.
排除标准
- •1.allergy to glycopyrrolate; 2.laparoscopic surgery; 3.liver or kidney dysfunction; 4.pre-existing abnormal electrocardiogram such as bradycardia; 5.concomitant glaucoma; 6.patients refusal to participate.
研究组 & 干预措施
Group L
The HR at 10 minutes after the start of surgery was considered as the baseline HR. Patients were divided into two groups based on their baseline HR: Group L: Baseline HR 40-60 beats/min.
干预措施: Glycopyrrolate (Drug)
Group H
The HR at 10 minutes after the start of surgery was considered as the baseline HR. Patients were divided into two groups based on their baseline HR: Group H: Baseline HR 60-100 beats/min.
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
the maximum increase ratio of HR
时间窗: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
The maximum increase ratio of HR =∆HR/\[HR at T1\]) .
The maximum increase of HR
时间窗: before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection
Calculation of the maximum increase of HR (∆HR): The increase in heart rate (HR) at 30 minutes after the administration of glycopyrrolate (T2) compared to 10 minutes after the start of surgery (T1) was calculated as the maximum increase of HR.
次要结局
- HRV frequency indexes(before induction of general anesthesia; 10 min after operation beginning; 30 min after glycopyrrolate injection)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University