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

16 juillet 2026 mis à jour par: General Hospital of Ningxia Medical University

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

108

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Yinchuan, Chine
        • Recrutement
        • General Hospital of Ningxia Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Pretreated Rocuronium Group
Médicament: Rocuronium Bromide (Pretreatment Injection)
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
Comparateur actif: Conventional Administration Group
Médicament: Rocuronium Bromide (Conventional Injection)
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Neuromuscular blockade onset time
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Systolic Blood Pressure (SBP)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

General Hospital of Ningxia Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

4 juillet 2026

Première soumission répondant aux critères de contrôle qualité

16 juillet 2026

Première publication (Réel)

21 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KYLL-2026-0131

Plan pour les données individuelles des participants (IPD)

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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