About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Remifentanil
- Ketamine