Efficacy and Hemodynamic Safety of Low-dose Propofol Plus High-dose Alfentanil in Rapid Sequence Induction: A Prospective Non-randomized Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Post-induction hypotension
研究概览
简要总结
This study compares four different anesthesia induction regimens to see which one provides the most stable blood pressure and heart rate during rapid sequence intubation. A total of 172 patients undergoing elective surgery will receive one of four combinations of propofol and opioids (alfentanil or sufentanil). The main outcomes are hypotension (low blood pressure), inadequate blunting of the stress response to intubation, and intubating conditions. The study aims to determine whether a lower dose of propofol combined with a higher dose of alfentanil can improve hemodynamic stability without compromising the quality of tracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The anesthesia nurse who assessed intubating conditions (Steyn modified Helbo-Hansen score) was blinded to the group allocation. Hemodynamic data were collected by a separate research nurse who was not involved in clinical management or subsequent data analysis.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Age 18 to 60 years
- •Body mass index (BMI) 18 to 30 kg/m²
- •Scheduled for elective surgery at Aoyang Hospital Affiliated to Jiangsu University
排除标准
- •Hypertension, diabetes mellitus, or cardiopulmonary dysfunction
- •Difficult airway
- •History of anesthetic drug allergy
- •Chronic sedative or analgesic use
- •Preoperative volume depletion
- •Overt painful stimuli
结局指标
主要结局
Post-induction hypotension
时间窗: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Mean arterial pressure (MAP) \< 60 mmHg for at least 2 consecutive time points during T1-T5. MAP \< 50 mmHg at any time point is recorded separately as severe hypotension.
Substantial heart rate decline
时间窗: T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).
Maximum decrease in heart rate (HR) ≥ 20% from the baseline value (T0) during T1-T5.
Inadequate blunting of intubation response
时间窗: Measured at T2 (immediately after intubation).
Meeting either of the following criteria at T2: (a) HR \> T0 × 1.2 and MAP ≥ T0 × 0.85 (i.e., MAP decline \<15%), excluding reflex tachycardia secondary to hypotension; or (b) MAP \> T0 × 1.2.
次要结局
- Intubating conditions(Assessed at the time of tracheal intubation.)
- Use of vasoactive agents(T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).)
- Other adverse events(T1 to T5 (from immediately before intubation to 5 minutes after tracheal intubation).)
研究者
Zhen Xu
Associate Chief Anesthesiologist
Aoyang Hospital Affiliated to Jiangsu University