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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent

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

Treatment groups

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators