- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716891
Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: xiaoya chen
- Phone Number: 8618295266516
- Email: chenxiaoya0314@163.com
Study Locations
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-
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Yinchuan, China
- Recruiting
- General Hospital of Ningxia Medical University
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Contact:
- xiaoya chen
- Phone Number: 8618295266516
- Email: chenxiaoya0314@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pretreated Rocuronium Group
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Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
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Active Comparator: Conventional Administration Group
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Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuromuscular blockade onset time
Time Frame: Within 5 minutes after completion of rocuronium-bromide injection
|
The time interval from injection of rocuronium bromide to maximum neuromuscular block effect
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Within 5 minutes after completion of rocuronium-bromide injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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。
|
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。
|
Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
|
|
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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。
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Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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|
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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。
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Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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|
|
Cardiac Output (CO)
Time Frame: 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. |
Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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|
Stroke Volume (SV)
Time Frame: Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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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. |
Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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Systemic Vascular Resistance (SVR)
Time Frame: 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. |
Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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Injection Pain
Time Frame: Pain assessment is performed within 5 minutes after completion of rocuronium injection.
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Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain: 0 = No limb contraction or twitching;
Subjects with a score ≥1 are defined as having injection pain. |
Pain assessment is performed within 5 minutes after completion of rocuronium injection.
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Limb Withdrawal Response
Time Frame: Assessment shall be completed within 5 minutes after rocuronium injection.
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Four-point grading scale for evaluating limb withdrawal reaction induced by injection pain: 0 = No limb contraction or twitching;
Subjects with a score ≥1 are defined as having injection pain. |
Assessment shall be completed within 5 minutes after rocuronium injection.
|
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Adverse Events
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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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. |
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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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLL-2026-0131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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