Sedation Methods in PTBD: How Two Regimens Compare for Quality and Recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center trial compares two commonly used sedation regimens during percutaneous transhepatic biliary drainage in adults with biliary obstruction and comorbidities. Participants are assigned to propofol–remifentanil or propofol–ketamine with target Ramsay 3–4, and monitored for recovery time, pain, satisfaction, and safety. The study uses standard monitoring and evaluates hemodynamics, pain scores, and adverse events to determine which approach offers better recovery and procedural quality in frail and elderly patients. Primary Outcome: recovery time via the Modified Aldrete Score. Secondary outcomes include procedure quality, patient and operator satisfaction, and incidence of sedation-related events. The trial aims to define an optimal sedation strategy for high-risk PTBD patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Ankara Bilkent City Hospital
  Ankara, Ankara, Turkey (Türkiye) Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.