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

NCT07640243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-06-10

No results posted yet for this study

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

Interventions

DRUG

Remifentanil

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

DRUG

Ketamine

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

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-05-30
Completion
2026-06-10

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640243 on ClinicalTrials.gov