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- Ensaio Clínico NCT07640243
Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Percutaneous transhepatic biliary drainage (PTBD) is a therapeutic procedure commonly performed in patients with biliary obstruction when surgical intervention or endoscopic retrograde cholangiopancreatography is not feasible. These patients frequently present with advanced age, malignancy, cholangitis, and significant comorbidities, making them particularly vulnerable to sedation-related complications.
Procedural sedation and analgesia are commonly used during interventional radiology procedures to ensure patient comfort, immobility, and procedural success. However, inadequate sedation may result in patient movement, increased anxiety, procedural failure, and complications, whereas excessive sedation may lead to hemodynamic instability, respiratory depression, and delayed recovery, especially in frail patients.
In this study, two commonly used sedation regimens-propofol combined with remifentanil and propofol combined with ketamine-will be compared. Both regimens are routinely used in non-operating room anesthesia settings in our institution. Patients will be randomly assigned in a 1:1 ratio to one of the two groups. Standard monitoring will be applied, including non-invasive blood pressure, electrocardiography, and pulse oximetry, with supplemental oxygen administered via nasal cannula.
Sedation depth will be targeted to a Ramsay Sedation Score of 3-4 and assessed every five minutes during the procedure. Hemodynamic parameters, oxygen saturation, pain scores, recovery time, and adverse events such as hypotension, bradycardia, hypoxia, nausea, vomiting, and airway interventions will be recorded. Recovery will be evaluated using the Modified Aldrete Score at two-minute intervals until adequate recovery is achieved.
The primary objective of the study is to compare recovery times between the two sedation regimens. Secondary objectives include comparison of pain intensity, patient and operator satisfaction, total drug consumption, procedural tolerance, and incidence of adverse events. The findings of this study aim to contribute to safer and more effective sedation strategies for PTBD procedures in high-risk patient populations.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ankara
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Ankara, Ankara, Turquia (Türkiye), 06800
- Recrutamento
- Ankara Bilkent City Hospital
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Contato:
- Mücahid MD Mutlu, Resident
- Número de telefone: +905078260298
- E-mail: mucahid.mutlu@gmail.com
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Contato:
- Mücahid Mutlu
- Número de telefone: +905078260298
- E-mail: mucahid.mutlu@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and/or biliary stenting
- ASA physical status II-IV
- Fasting time of at least 6 hours prior to the procedure
- Ability to provide written informed consent
Exclusion Criteria:
- Inability to provide informed consent or to complete study assessments (e.g., Ramsay Sedation Scale, FRAIL scale, Numeric Rating Scale)
- Clinical diagnosis of Alzheimer's Disease
- Clinical diagnosis of demantia
- Known allergy or hypersensitivity to propofol, remifentanil, ketamine, ondansetron, or deksketoprofen
- Grade 3-4 aortic, mitral, or tricuspid valve disease
- Advanced or decompensated heart failure (ejection fraction <25%)
- Emergency procedures
- Refusal to participate in the study
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 |
|---|---|
|
Experimental: Propofol-Remifentanil
Participants received intravenous propofol 0.5 mg/kg followed by a continuous intravenous remifentanil infusion initiated at 0.10-0.18
mcg/kg/min during the procedure.
The remifentanil infusion rate was adjusted within the specified range according to clinical response to maintain adequate sedation, analgesia, and hemodynamic stability throughout the procedure.
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Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
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Experimental: Propofol-Ketamine
IParticipants received intravenous propofol 0.5 mg/kg followed by intravenous ketamine 0.3 mg/kg.
Additional intravenous ketamine 5 mg was administered every 5 minutes as needed during the procedure to maintain the target sedation level and hemodynamic stability.
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Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recovery Time
Prazo: From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
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Time to achieve adequate recovery assessed using the Modified Aldrete Score.
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From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemodynamic Stability
Prazo: Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
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Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure.
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Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
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Pain Intensity
Prazo: Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
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Pain intensity assessed using the Numeric Rating Scale (NRS)
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Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
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Sedation Depth
Prazo: Every 5 minutes during the procedure, assessed up to 30 minutes.
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Sedation level assessed using the Ramsay Sedation Scale.
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Every 5 minutes during the procedure, assessed up to 30 minutes.
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Adverse Events
Prazo: Perioperatively and through the recovery period, assessed up to 30 minutes.
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Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.
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Perioperatively and through the recovery period, assessed up to 30 minutes.
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Patient and Operator Satisfaction
Prazo: Immediately after the procedure
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Patient and operator satisfaction assessed after completion of the procedure.
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Immediately after the procedure
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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
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Doenças das vias biliares
- Doenças das vias biliares
- Neoplasias
- Colangite
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Hidrocarbonetos
- Ciclohexanos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Ácidos, acíclico
- Ácidos carboxílicos
- Piperidinas
- Propionatos
- Remifentanil
- Cetamina
Outros números de identificação do estudo
- TABED-1-25-1188
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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