drugset / Trial / NCT07640243

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

NCT07640243

Recruiting 98 enrolled Ankara City Hospital Bilkent
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-02-01
Primary completion
2026-05-30
Completion
2026-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.3 mg/kg Intravenous
Subject Ketamine Small molecule 5 mg Intravenous
Subject Remifentanil Small molecule 0.1 ug/kg Intravenous
Subject Remifentanil Small molecule 0.18 ug/kg Intravenous

Indications