NCT05532449尚未招募不适用
Low-dose Dezoxide Suppresses Sufentanil-induced Cough During Induction of General Anesthesia in Patients Undergoing Cardiac Surgery: a Prospective, Randomized, Controlled Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 176 人开始时间: 2022年9月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 主要终点
- sufentanil-induced cough
研究概览
简要总结
Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 <90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form
排除标准
- •Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.
研究组 & 干预措施
Dezocine
Experimental
intravenous dezocine (0.03mg/kg diluted to 5 ml)
干预措施: Intravenous dizocine (Drug)
结局指标
主要结局
sufentanil-induced cough
时间窗: 2 minutes after intubation
rate and severity of cough after sufentanil injection
次要结局
- SpO2(2 minutes after intubation)
- heart rate(2 minutes after intubation)
- mean arterial pressure(2 minutes after intubation)
研究者
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