Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery (NCT07640243) | Clinical Trial Compass
RecruitingNot Applicable
Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Turkey (Türkiye)98 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recovery Time
Timeframe: From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes