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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07709975
Analgesia Methods and Early Mobilization in Geriatric ICU Patients After Major Surgery
Effect of Analgesia Methods on Early Mobilization and Patient Satisfaction in Geriatric Patients Admitted to Intensive Care After Major Surgery
Visão geral do estudo
Status
Condições
Descrição detalhada
Early mobilization is a key component of enhanced postoperative recovery in older adults and has been associated with reduced functional decline, shorter intensive care unit (ICU) and hospital stays, and fewer postoperative complications. However, postoperative pain remains one of the main barriers to early mobilization. Although several analgesic strategies are routinely used after major surgery, their comparative effects on functional recovery in critically ill geriatric patients have not been well established in real-world clinical practice.
This is a prospective, single-center observational cohort study designed to evaluate the association between routinely administered postoperative analgesic techniques and early postoperative recovery in geriatric surgical patients requiring ICU admission. Because the study is observational, all perioperative and postoperative management, including the choice of analgesic technique, will be determined exclusively by the treating clinicians according to institutional practice. No treatment allocation, randomization, or protocol-driven intervention will be performed.
Clinical and perioperative data will be collected prospectively from routine medical records, anesthesia documentation, ICU electronic records, and nursing charts using standardized case report forms. Data quality will be ensured through predefined data collection procedures and verification before database entry. The study does not require any additional diagnostic tests, invasive procedures, blood sampling, or alterations to routine patient care.
The findings are expected to provide real-world evidence regarding the relationship between commonly used postoperative analgesic strategies and recovery after major surgery in older adults. These results may help optimize perioperative pain management protocols and support future comparative and interventional studies aimed at improving functional recovery in the geriatric surgical population.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Zekeriya Ervatan, MD
- Número de telefone: +90505 598 32 48
- E-mail: zek.ervatan@gmail.com
Locais de estudo
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Istanbul
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Istanbul, Istanbul, Turquia (Türkiye), 34384
- Recrutamento
- University of Health Sciences, Prof. Dr. Cemil Taşçıoğlu City Hospital
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Contato:
- Zekeriya Ervatan, MD
- Número de telefone: +90505 598 32 48
- E-mail: zek.ervatan@gmail.com
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Contato:
- Beyzanur Aydoğdu, MD
- Número de telefone: +90531 367 70 76
- E-mail: beyzaaydogan7714@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age 65 years or older
- ASA physical status classification I-IV
- Admitted to the intensive care unit (ICU) following major surgery
- ICU stay of at least 24 hours
Exclusion Criteria:
- Previously diagnosed advanced-stage dementia
- Inability to assess consciousness due to severe neurological deficit
- ICU stay of less than 24 hours
- Incomplete or insufficient clinical data
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Systemic Analgesia
Patients who receive systemic (intravenous) opioid analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
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Standard-of-care intravenous opioid-based analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
|
|
Epidural Analgesia
Patients who receive epidural analgesia as determined by the treating clinical team.
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Standard-of-care epidural analgesia administered per routine clinical practice.
|
|
Peripheral Nerve Block
Patients who receive peripheral nerve block analgesia, with or without multimodal analgesic agents, as determined by the treating clinical team.
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Standard-of-care peripheral nerve block analgesia, with or without additional non-opioid multimodal agents, administered per routine clinical practice.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to First Mobilization
Prazo: From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
|
Time (in hours) from ICU admission to the first time the patient achieves at least one level of mobilization - sitting at the bedside, standing, or walking - based on the ICU Mobility Scale.
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From ICU admission until first achievement of ICU Mobility Scale level ≥1, assessed for up to 30 days.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Pain Score
Prazo: At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
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Pain intensity assessed using the Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
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At ICU admission, and at 6, 12, 24, and 48 hours after ICU admission
|
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Incidence of Delirium
Prazo: Assessed at least once daily for the first 3 days of ICU stay
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Presence of delirium assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), reported as positive or negative.
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Assessed at least once daily for the first 3 days of ICU stay
|
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Length of ICU Stay
Prazo: From ICU admission to ICU discharge, up to approximately 30 days
|
Total number of days the patient remains in the intensive care unit.
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From ICU admission to ICU discharge, up to approximately 30 days
|
|
Total Opioid Consumption
Prazo: From ICU admission to ICU discharge, up to approximately 30 days
|
Cumulative opioid dose administered, expressed as morphine milligram equivalents (mg).
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From ICU admission to ICU discharge, up to approximately 30 days
|
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Patient Satisfaction with Analgesia
Prazo: Assessed once, prior to ICU discharge
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Patient-reported satisfaction with pain management assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
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Assessed once, prior to ICU discharge
|
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Incidence and Type of Postoperative Complications
Prazo: From ICU admission to ICU discharge, up to approximately 30 days
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Presence and type of any postoperative complications recorded during ICU stay.
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From ICU admission to ICU discharge, up to approximately 30 days
|
Colaboradores e Investigadores
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
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Complicações pós-operatórias
- Processos Patológicos
- Confusão
- Manifestações Neurocomportamentais
- Distúrbios Neurocognitivos
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Adesão e Cumprimento do Tratamento
- Comportamento de saúde
- Fragilidade
- Delírio de emergência
- Dor, Pós-operatório
- Delírio
- Satisfação do paciente
- Anestesia e analgesia
- Analgesia
- Analgesia, epidural
Outros números de identificação do estudo
- CT-ERHO-AR-BA-04
- E-48670771-514.99-316163880 (Outro identificador: University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital Clinical Research Ethics Committee)
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