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Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery

8 de junio de 2026 actualizado por: Ankara City Hospital Bilkent

Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects

This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures. A total of 96 adult patients undergoing elective PTBD or biliary stenting will be randomized to receive either propofol-remifentanil or propofol-ketamine sedation. The primary outcome is recovery time assessed using the Modified Aldrete Score. Secondary outcomes include procedure quality, pain scores, patient and operator satisfaction, hemodynamic stability, and the incidence of sedation-related adverse events. The study is designed to determine the optimal sedation strategy for PTBD, particularly in fragile and elderly patient populations.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

98

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

    • Ankara
      • Ankara, Ankara, Turquía (Türkiye), 06800
        • Reclutamiento
        • Ankara Bilkent City Hospital
        • Contacto:
        • Contacto:

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

No

Descripción

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

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
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.
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recovery Time
Periodo de tiempo: From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
Time to achieve adequate recovery assessed using the Modified Aldrete Score.
From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hemodynamic Stability
Periodo de tiempo: Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure.
Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
Pain Intensity
Periodo de tiempo: Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Pain intensity assessed using the Numeric Rating Scale (NRS)
Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Sedation Depth
Periodo de tiempo: Every 5 minutes during the procedure, assessed up to 30 minutes.
Sedation level assessed using the Ramsay Sedation Scale.
Every 5 minutes during the procedure, assessed up to 30 minutes.
Adverse Events
Periodo de tiempo: Perioperatively and through the recovery period, assessed up to 30 minutes.
Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.
Perioperatively and through the recovery period, assessed up to 30 minutes.
Patient and Operator Satisfaction
Periodo de tiempo: Immediately after the procedure
Patient and operator satisfaction assessed after completion of the procedure.
Immediately after the procedure

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)

1 de febrero de 2026

Finalización primaria (Estimado)

30 de mayo de 2026

Finalización del estudio (Estimado)

10 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

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

8 de junio de 2026

Última verificación

1 de enero 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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