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

NCT07640243 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara City Hospital Bilkent

Phase

Not applicable

Started

2026-02-01

Last updated

2026-06-10

Condition(s) studied

FragilityBiliary ObstructionCholangitisMalignancy

Investigational drug(s) / intervention(s)

Remifentanil →Ketamine →

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and/or biliary stenting * ASA physical status II-IV * Fasting time of at least 6 hours prior to the procedure * Ability to provide written informed consent Exclusion Criteria: * Inability to provide informed consent or to complete study assessments (e.g., Ramsay Sedation Scale, FRAIL scale, Numeric Rating Scale) * Clinical diagnosis of Alzheimer's Disease * Clinical diagnosis of demantia * Known allergy or hypersensitivity to propofol, remifentanil, ketamine, ondansetron, or deksketoprofen * Grade 3-4 aortic, mitral, or tricuspid valve disease * Advanced or decompensated heart failure (ejection fraction \<25%) * Emergency procedures * Refusal to participate in the study

Primary outcome measure(s)

Recovery Time — From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
Time to achieve adequate recovery assessed using the Modified Aldrete Score.

Trial sites (1)

Facility	City	Region	Status
Ankara Bilkent City Hospital	Ankara	Ankara	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07640243 on ClinicalTrials.gov ↗ ← All trials in Turkey