Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- hemodynamic stability success
研究概览
简要总结
This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.
Endotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.
A total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg/kg.
All participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.
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, Care Provider, 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
- •Age 18 to 65 years.
- •American Society of Anesthesiologists physical status I or II.
- •Scheduled for elective non-cardiac surgery.
- •Planned general anaesthesia with endotracheal intubation.
排除标准
- •Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.
- •Current use of β-blockers.
- •History of chronic drug use or alcohol abuse.
- •Hepatic or renal impairment.
- •Known allergy to any study drug.
- •Anticipated difficult airway.
- •Any other condition that may affect the conduct of the study.
研究组 & 干预措施
Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Metoprolol (MET) (Drug)
Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg
干预措施: Sufentanil (Drug)
Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg
干预措施: Sufentanil (Drug)
结局指标
主要结局
hemodynamic stability success
时间窗: within 0-10 min after intubation
次要结局
- incidence of tachycardia(within 0-10 min after intubation)
- incidence of hypotension(within 0-10 min after intubation)
- incidence of hypertension(within 0-10 min after intubation)
- incidence of bradycardia(within 0-10 min after intubation)
研究者
Yanhua Guo
Associate Chief Physician
Fujian Provincial Hospital