Elective Surgery, General Anesthesia
Conditions
Keywords
Rocuronium bromide, Onset time, Hemodynamics
Brief summary
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.
Interventions
DRUGRocuronium Bromide (Pretreatment Injection)
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
DRUGRocuronium Bromide (Conventional Injection)
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuromuscular blockade onset time | Within 5 minutes after completion of rocuronium-bromide injection | The time interval from injection of rocuronium bromide to maximum neuromuscular block effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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。 | 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. |
| Stroke Volume (SV) | Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。 | 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. |
| 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。 | 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. |
| Injection Pain | Pain assessment is performed within 5 minutes after completion of rocuronium injection. | 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. |
| Limb Withdrawal Response | Assessment shall be completed within 5 minutes after rocuronium injection. | 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. |
| 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. | 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. |
Countries
China
Contacts
CONTACTxiaoya chen
Outcome results
None listed