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RECRUITING
NCT07640243
NA

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

Sponsor: Ankara City Hospital Bilkent

View on ClinicalTrials.gov

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

DRUG

Remifentanil

Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.

DRUG

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)