Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Neuromuscular blockade onset time
研究概览
简要总结
This is a single-center, prospective, randomized, controlled trial comparing pre-injection versus standard bolus administration of rocuronium bromide for general anesthesia induction. A total of 108 adult patients (18-65 years, ASA I-III) scheduled for elective surgery requiring endotracheal intubation will be enrolled and randomized 1:1 to either the pre-injection group or control group.
The pre-injection group will receive rocuronium 0.06 mg/kg as a priming dose followed by 0.54 mg/kg 3 minutes later. The control group will receive rocuronium 0.6 mg/kg as a single bolus. All patients will receive standardized anesthesia induction with midazolam and propofol.
The primary outcome is neuromuscular blockade onset time (seconds). Secondary outcomes include hemodynamic parameters (SBP, DBP, MAP, HR, CO, SV, SVR), injection pain incidence, and adverse events.
This study aims to investigate whether pre-injection of rocuronium can shorten neuromuscular blockade onset time while maintaining hemodynamic stability compared to standard bolus administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Aged from 18 to 65 years old
- •American Society of Anesthesiologists (ASA) physical status classification Ⅰ, Ⅱ or Ⅲ
- •Elective surgery requiring general anesthesia with tracheal intubation
- •Able to understand the study and voluntarily sign written informed consent
- •Male or female, no gender restriction
排除标准
- •Severe hepatic dysfunction (ALT/AST > 3 times the upper limit of normal) or renal dysfunction (creatinine > 2 times the upper limit of normal)
- •Central nervous system diseases or severe neuromuscular disorders
- •Severe arrhythmia or cardiac dysfunction (NYHA class Ⅲ-Ⅳ, or ejection fraction EF < 30%)
- •Known hypersensitivity or allergy to rocuronium, midazolam, propofol or other study-related drugs
- •Refusal to participate in this clinical trial
- •Pregnant or breastfeeding women
- •History of predicted difficult airway requiring awake tracheal intubation
- •Contraindications to rapid sequence induction
结局指标
主要结局
Neuromuscular blockade onset time
时间窗: Within 5 minutes after completion of rocuronium-bromide injection
The time interval from injection of rocuronium bromide to maximum neuromuscular block effect
次要结局
- Systolic Blood Pressure (SBP)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Diastolic Blood Pressure (DBP)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Mean Arterial Pressure (MAP)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Heart Rate (HR)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Cardiac Output (CO)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Stroke Volume (SV)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Systemic Vascular Resistance (SVR)(Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。)
- Injection Pain(Pain assessment is performed within 5 minutes after completion of rocuronium injection.)
- Limb Withdrawal Response(Assessment shall be completed within 5 minutes after rocuronium injection.)
- Adverse Events(Continuous assessment from the start of anesthesia induction until the end of surgery; the maximum assessment period is the perioperative period of a single operation.)