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Recruiting NCT07716891

Effect of Pre-injection of Rocuronium on Neuromuscular Blockade Onset Time and Hemodynamics During General Anesthesia Induction

No phase Interventional General Anesthesia Elective Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rocuronium Bromide (Pretreatment Injection), Rocuronium Bromide (Conventional Injection).
Who it may be relevant to
Registry conditions: General Anesthesia, Elective Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Drug Rocuronium Bromide (Pretreatment Injection)
    Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
  • Drug Rocuronium Bromide (Conventional Injection)
    Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

Primary outcome measures

  • Neuromuscular blockade onset time [Time frame: Within 5 minutes after completion of rocuronium-bromide injection]
Secondary outcome measures (10)
  • 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) [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) [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) [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 [Time frame: 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • General Hospital of Ningxia Medical University — Yinchuan

Identifiers

NCT: NCT07716891 · KYLL-2026-0131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗