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Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Sponsor: Ankara City Hospital Bilkent
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.
Official title: Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2026-02-01
Completion Date
2026-06-10
Last Updated
2026-06-10
Healthy Volunteers
No
Interventions
Remifentanil
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
Ketamine
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.
Locations (1)
Ankara Bilkent City Hospital
Ankara, Ankara, Turkey (Türkiye)