Clinical trial · Interventional
Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction | — | UNRESOLVED | — |
| Cholangitis | — | UNRESOLVED | — |
| Fragility | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Remifentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Propofol-Remifentanil
- description
- Participants received intravenous propofol 0.5 mg/kg followed by a continuous intravenous remifentanil infusion initiated at 0.10-0.18 mcg/kg/min during the procedure. The remifentanil infusion rate was adjusted within the specified range according to clinical response to maintain adequate sedation, analgesia, and hemodynamic stability throughout the procedure.
- interventionNames
- Drug: Remifentanil
- type
- EXPERIMENTAL
- label
- Propofol-Ketamine
- description
- IParticipants received intravenous propofol 0.5 mg/kg followed by intravenous ketamine 0.3 mg/kg. Additional intravenous ketamine 5 mg was administered every 5 minutes as needed during the procedure to maintain the target sedation level and hemodynamic stability.
- interventionNames
- Drug: Ketamine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available