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The Effect of Remifentanil on the Objectively Measured Pressure Pain Threshold

30 de abril de 2026 actualizado por: Arnaud Bollens, Université Libre de Bruxelles

L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement

It is a clinical study investigating the relationship between objectively measured pain threshold and the need for escalating doses of remifentanyl opioids. This study is expected to include approximately 40 participants.

The aim of the study is to objectively measure the analgesic effect of an increasing dose of opioids just before anesthesia.

Descripción general del estudio

Descripción detallada

This is a prospective interventional study. Participants will undergo controlled pressure stimulation using an Algometer device to determine their pressure pain threshold (PPT).

Pressure pain threshold will be assessed at baseline (0 ng/mL) and during stepwise increasing target-controlled intravenous remifentanil concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.

Investigators hypothesize that increasing plasma concentrations of remifentanil will be associated with a corresponding increase in pressure pain threshold.

In addition, postoperative analgesic consumption will be recorded following surgery. This will allow the investigators to explore a potential association between intraoperative pressure pain threshold modulation and postoperative pain outcomes or analgesic requirements.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

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.

Ubicaciones de estudio

    • Brussels Capital
      • Brussels, Brussels Capital, Bélgica, 1070
        • HUB Erasme

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:

  • Adult patients who are able to volunteer
  • ASA 1, 2and 3

Exclusion Criteria:

  • Refusal to participate;

    • Body mass index (BMI) > 30 kg/m²;
    • Allergy to any medication used for anesthesia;
    • Chronic pain or regular use of analgesics;
    • Severe ventricular dysfunction, pulmonary hypertension, or uncontrolled arrhythmia;
    • Non-elective surgery;
    • Participation in another study within the last 3 months;
    • Pregnancy or breastfeeding;
    • Severe renal or hepatic impairment

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: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption

This is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored.

Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.

Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented.

Upon arrival in the operating room, the patient will undergo standard monitoring, including non-invasive blood pressure, electrocardiography (ECG), pulse oximetry (SpO₂), bispectral index (BIS™), and train-of-four (TOF) monitoring.

An intravenous (IV) line will be placed, and crystalloid infusion will be initiated.

Mechanical pain threshold will then be assessed using a Medoc algometer. Measurements will be performed on the dorsum of the non-dominant hand. Four measurements will be obtained at different target plasma concentrations of remifentanil(Ultiva®): 0, 1, 2, and 3 ng/mL. Remifentanil will be administered using a target-controlled infusion (TCI) system based on the Minto pharmacokinetic model.

Following completion of these measurements, standardized intravenous anesthesia will be induced and maintained using propofol (propolipid®), remifentanil, and rocuronium (B.Braun®).

Total perioperative consumption of remifentanil and propofol will be recorded.

At the end of the surgical procedure, intravenous acetaminophen 1 g and a 4 mg morphine bolus will be administered.

Upon arrival in the post-anesthesia care unit (PACU), pain will be assessed using the visual analogue scale (VAS). During the first 24 postoperative hours, analgesia will be provided via a patient-controlled analgesia (PCA) pump delivering 2 mg intravenous HCL morphine (Sterop®) boluses on demand.

The PCA settings will follow a 2/10/20 regimen: 2 mg morphine per demand dose, a 10-minute lockout interval, and a maximum dose of 20 mg over 4 hours.

The use of acetaminophen as adjunct analgesia is permitted; however, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), piritramide, and magnesium are prohibited.

Pain scores (VAS) will be reassessed at 12 and 24 hours postoperatively.

All adverse events (e.g., nausea, delirium) will be monitored and recorded during the 24-hour postoperative period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measurement of the variation in the pressure pain threshold
Periodo de tiempo: Measurement of the mechanical pressure pain threshold will be initiated upon the participant's arrival in the operating room. The procedure is expected to last approximately 10-15 minutes and will be followed by induction of anesthesia.

Change in mechanical pain threshold measured objectively using an algometer (AlgoMed®) at increasing plasma concentrations of remifentanil (0, 1, 2, and 3 ng/mL) during the preoperative period.

The pain threshold is defined as the pressure (in kilopascals) at which the patient first reports pain during a standardized mechanical stimulus.

Measurement of the mechanical pressure pain threshold will be initiated upon the participant's arrival in the operating room. The procedure is expected to last approximately 10-15 minutes and will be followed by induction of anesthesia.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between preoperative pain threshold and total postoperative morphine consumption
Periodo de tiempo: From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.

Correlation between preoperative pain threshold and total postoperative morphine consumption (particularly within the first 24 hours using patient-controlled analgesia).

Postoperative pain scores assessed using standard pain scales in the post-anesthesia care unit.

Intraoperative opioid (remifentanil) consumption in a standardized anesthesia setting.

Post operative opioid (PCA, morphine) consumption recorded within the first 24H post surgery.

From the day of surgery, prior to anesthesia induction, until 24 hours postoperatively.

Colaboradores e Investigadores

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

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 (Actual)

26 de enero de 2026

Finalización primaria (Estimado)

15 de junio de 2026

Finalización del estudio (Estimado)

15 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

17 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2026

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

30 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

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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