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

ConditionsFragilityBiliary ObstructionCholangitisMalignancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remifentanil

    Drug

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

  • Ketamine

    Drug

    Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Propofol-RemifentanilExperimental treatment 1 intervention
Group B: Propofol-KetamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recovery Time

Time to achieve adequate recovery assessed using the Modified Aldrete Score.

Time frame
From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes

Secondary outcomes

1

Hemodynamic Stability

Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure.

Time frame
Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
2

Pain Intensity

Pain intensity assessed using the Numeric Rating Scale (NRS)

Time frame
Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
3

Sedation Depth

Sedation level assessed using the Ramsay Sedation Scale.

Time frame
Every 5 minutes during the procedure, assessed up to 30 minutes.
4

Adverse Events

Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.

Time frame
Perioperatively and through the recovery period, assessed up to 30 minutes.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Source ClinicalTrials.gov
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