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

RecruitingNAAges 18 Years - anyAllAnkara City Hospital Bilkent
NCT07640243 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Remifentanil
  • Ketamine
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Where

1 site
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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