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

StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
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
(from sponsor)		 Fragility, Biliary Obstruction, Cholangitis, Malignancy
Related terms Cholangitis, Neoplasms
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov