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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malásia, 59100
- Universiti Malaya Medical Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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Outro: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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post operative opioid consumption
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Efeitos fisiológicos das drogas
- Agentes do Sistema Nervoso Periférico
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Sensorial
- Analgésicos
- Narcóticos
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Agentes do sistema nervoso central
- Analgésicos, Opioides
Outros números de identificação do estudo
- 202541314965
- BKP004-2025-ECRG (Número de outro subsídio/financiamento: EARLY CAREER RESEARCH GRANT (BKP-ECRG) 2025 UNIVERSITI MALAYA)
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