Clinical Trial

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

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07640243
Lead Sponsor Ankara City Hospital Bilkent
Conditions Fragility, Biliary Obstruction, Cholangitis, Malignancy
Enrollment 98 participants
Start Date 2026-02-01
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-06-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-10