Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial
Effective intraoperative and postoperative pain management is critical for patient comfort and recovery, yet traditional methods for assessing pain under general anaesthesia are limited by their subjective nature and reliance on vital signs. Automated pupillometry, which gives the parameters of the pupillary light reflex (PLR) components, offers an objective and quantitative approach to evaluating nociception and pain.
This study aims to evaluate the effectiveness of the automated pupillometry in enhancing early postoperative pain control and to assess its utility in guiding opioid administration during the perioperative period.
A prospective, non-blinded randomized controlled trial will be conducted with 68 patients undergoing laparotomy for gastrointestinal surgery. Participants will be randomly assigned to either an interventional group, where analgesia is guided by automated pupillometry measurements, or a control group receiving standard pain management. Key outcomes include the time to first rescue analgesia, self-reported pain scores, opioid consumption. The automated pupillometry measurements will be taken at key surgical moments, including before induction, pre-incision, and during recovery.
Pain scores and rescue analgesia use will be compared between groups using appropriate statistical tests, and Kaplan-Meier survival curves will analyze time to first rescue analgesia. Regression analyses will explore the relationship between pupillometry readings and postoperative pain.
It is anticipated that the automated pupillometry guided group will experience longer intervals before requiring rescue analgesia and report lower pain scores, suggesting improved pain management and reduced opioid use.
This study could validate automated pupillometry as an innovative tool for optimizing postoperative pain management, potentially improving patient outcomes by enabling more precise and effective analgesia in surgical settings.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 59100
- Universiti Malaya Medical Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 1. Patients aged 18 - 70 years old scheduled for elective/emergency laparotomy with clear awareness and good communication
- 2. ASA (American Society of Anaesthesiologists) physical status I-III
- 3. Expected to have moderate to severe pain in the early postoperative period
Exclusion Criteria:
- 1. Patient with known pupillary abnormality (such as anisocoria, pharmacologic dilation, previous intraocular surgery)
- 2. Pre-existing neurological disorder affecting pupillary reflexes
- 3. Patients on chronic opioid therapy or with a history of substance abuse
- 4. Non-consenting patients or those with cognitive impairments affecting informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Intervention
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml, titrated according to the anaesthetist's discretion. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. Additional analgesics could be administered as control arm. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.Anaesthetists will give rescue morphine when the pupillary diameter changes > 20% and repeat the measurement after 5 minutes |
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction.
Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml.
TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline after induction.
The automated pupillometry measurement is repeated 5 mins after increment.
Prior to skin closing, IV morphine 0.1 mg/kg during skin closing and automated pupillometry measurement is repeated to aim pupillary diameter is within 20% of baseline.
Analgesics is titrated according to the anaesthetist's discretion and reason is documented if it is deviated from the protocol.
For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins. For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia. |
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Otro: Control
Participants in the control group will receive anaesthetic and analgesic management as per the standard practice followed by the attending anaesthetist.
Additional analgesics, including intravenous paracetamol, intravenous parecoxib, and abdominal plane blocks, will be provided if there are no contraindications.
Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure.
At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.
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For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins. For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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post operative opioid consumption
Periodo de tiempo: first 24 hours post operatively
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the amount of post operative opioid consumption including rescue analgesia and patient controlled analgesia morphine usage would be recorded
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first 24 hours post operatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
Periodo de tiempo: automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
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To find the measurement changes or correlation with opioiod administration, and to analyse it statistically
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automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Depresores del sistema nervioso central
- Agentes del sistema sensorial
- Analgésicos
- Narcóticos
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Agentes del sistema nervioso central
- Analgésicos, Opioides
Otros números de identificación del estudio
- 202541314965
- BKP004-2025-ECRG (Otro número de subvención/financiamiento: EARLY CAREER RESEARCH GRANT (BKP-ECRG) 2025 UNIVERSITI MALAYA)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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