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

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Pretreated Rocuronium Group
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
Active Comparator: Conventional Administration Group
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

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
Within 5 minutes after completion of rocuronium-bromide injection

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。
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。
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。
Baseline (before rocuronium-bromide injection), 0.5-minute, 1-minute, 2-minute, 3-minute and 5-minute after rocuronium-bromide injection。
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。
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。

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。
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。
Injection Pain
Time Frame: 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.

Pain assessment is performed within 5 minutes after completion of rocuronium injection.
Limb Withdrawal Response
Time Frame: 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.

Assessment shall be completed within 5 minutes after rocuronium injection.
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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 4, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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