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

16 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

108

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
      • Yinchuan, Porcelana
        • Reclutamiento
        • General Hospital of Ningxia Medical University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Pretreated Rocuronium Group
Droga: Rocuronium Bromide (Pretreatment Injection)
Low-dose rocuronium bromide is injected intravenously in advance before anesthesia induction
Comparador activo: Conventional Administration Group
Droga: Rocuronium Bromide (Conventional Injection)
Rocuronium bromide is administered by standard routine intravenous injection during anesthesia induction

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neuromuscular blockade onset time
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic Blood Pressure (SBP)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

General Hospital of Ningxia Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2026

Publicado por primera vez (Actual)

21 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KYLL-2026-0131

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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