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

NCT07640243 | Recruiting DMC

• 1 other identifier: TABED-1-25-1188
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fragility; Biliary Obstruction; Cholangitis; Malignancy

Keywords

FRAGILITY; Percutaneous Transhepatic Biliary Drainage; SEDATION; KETAMINE; REMİFENTANIL

Outcome Measures

Primary Outcomes (1)

• Recovery Time

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

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

Secondary Outcomes (5)

• Hemodynamic Stability

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

• Pain Intensity

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

• Sedation Depth

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

• Adverse Events

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

• Patient and Operator Satisfaction

  Immediately after the procedure

Study Arms (2)

Propofol-Remifentanil

EXPERIMENTAL

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.

Drug: Remifentanil

Propofol-Ketamine

EXPERIMENTAL

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.

Drug: Ketamine

Interventions

Remifentanil DRUG

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

Propofol-Remifentanil

Ketamine DRUG

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

Propofol-Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cholangitis; Neoplasms

Interventions

Remifentanil; Ketamine

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: June 10, 2026
• Study Start: February 1, 2026
• Primary Completion: May 30, 2026
• Study Completion: June 10, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)