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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction
General Hospital of Ningxia Medical University
Yinchuan, China
RECRUITINGNeuromuscular blockade onset time
The time interval from injection of rocuronium bromide to maximum neuromuscular block effect
Time frame: Within 5 minutes after completion of rocuronium-bromide injection
Systolic Blood Pressure (SBP)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Heart Rate (HR)
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Cardiac Output (CO)
Measurement instrument: Non-invasive continuous blood pressure and cardiac output monitoring system (Model T20A). Measurement method: Finger cuff volume pulse wave plethysmography, the device automatically calculates real-time CO value, unit: L/min. Assessment method: Record stable CO value after waveform stabilization for 10 seconds at each time point; compare absolute value and percentage change vs baseline to evaluate the hemodynamic effect of rocuronium.
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Stroke Volume (SV)
Measurement instrument: Non-invasive continuous blood pressure and cardiac output monitoring system (Model T20A). Measurement method: Continuous finger pulse wave monitoring, automatic calculation of stroke volume (unit: mL/beat). Assessment method: Record stable SV readings at each time point and analyze dynamic changes compared with baseline.
Time frame: 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)
Measurement device: Non-invasive continuous blood pressure and cardiac output monitor (Model T20A). Measurement method: SVR (unit: dyn·s·cm-⁵) is automatically calculated by the monitor using real-time mean arterial pressure, central venous pressure and cardiac output. Assessment: SVR values were recorded once readings stabilized to assess changes in total peripheral vascular resistance after rocuronium administration.
Time frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
Injection Pain
Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain: 0 = No limb contraction or twitching; 1. = Only slight wrist movement, no movement of other arm joints; 2. = Entire arm movement/withdrawal involving elbow, shoulder and other joints; 3. = Systemic response with movements across multiple limbs beyond one single limb. Subjects with a score ≥1 are defined as having injection pain.
Time frame: Pain assessment is performed within 5 minutes after completion of rocuronium injection.
Limb Withdrawal Response
Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain: 0 = No limb contraction or twitching; 1. = Only slight wrist movement, no movement of other arm joints; 2. = Entire arm movement/withdrawal involving elbow, shoulder and other joints; 3. = Systemic response with movements across multiple limbs beyond one single limb. Subjects with a score ≥1 are defined as having injection pain.
Time frame: Assessment shall be completed within 5 minutes after rocuronium injection.
Adverse Events
Record adverse events occurring during perioperative period, including severe bradycardia (heart rate \<45 beats per minute), hypotension (mean arterial pressure MAP \<65 mmHg), various arrhythmias and allergic reactions. The number and incidence of each type of adverse event will be counted. Assessment method: Vital signs are continuously monitored intraoperatively. Anesthesiologists identify and record all eligible adverse events in real time, with documentation of onset time, duration and corresponding interventions.
Time frame: 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.
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