Biliary Obstruction, Cholangitis, Fragility, Malignancy
Conditions
Keywords
FRAGILITY, Percutaneous Transhepatic Biliary Drainage, SEDATION, KETAMINE, REMİFENTANIL
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.
Detailed description
Percutaneous transhepatic biliary drainage (PTBD) is a therapeutic procedure commonly performed in patients with biliary obstruction when surgical intervention or endoscopic retrograde cholangiopancreatography is not feasible. These patients frequently present with advanced age, malignancy, cholangitis, and significant comorbidities, making them particularly vulnerable to sedation-related complications. Procedural sedation and analgesia are commonly used during interventional radiology procedures to ensure patient comfort, immobility, and procedural success. However, inadequate sedation may result in patient movement, increased anxiety, procedural failure, and complications, whereas excessive sedation may lead to hemodynamic instability, respiratory depression, and delayed recovery, especially in frail patients. In this study, two commonly used sedation regimens-propofol combined with remifentanil and propofol combined with ketamine-will be compared. Both regimens are routinely used in non-operating room anesthesia settings in our institution. Patients will be randomly assigned in a 1:1 ratio to one of the two groups. Standard monitoring will be applied, including non-invasive blood pressure, electrocardiography, and pulse oximetry, with supplemental oxygen administered via nasal cannula. Sedation depth will be targeted to a Ramsay Sedation Score of 3-4 and assessed every five minutes during the procedure. Hemodynamic parameters, oxygen saturation, pain scores, recovery time, and adverse events such as hypotension, bradycardia, hypoxia, nausea, vomiting, and airway interventions will be recorded. Recovery will be evaluated using the Modified Aldrete Score at two-minute intervals until adequate recovery is achieved. The primary objective of the study is to compare recovery times between the two sedation regimens. Secondary objectives include comparison of pain intensity, patient and operator satisfaction, total drug consumption, procedural tolerance, and incidence of adverse events. The findings of this study aim to contribute to safer and more effective sedation strategies for PTBD procedures in high-risk patient populations.
Interventions
DRUGRemifentanil
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
DRUGKetamine
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes | Time to achieve adequate recovery assessed using the Modified Aldrete Score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Stability | Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure. | Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure. |
| Pain Intensity | Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery. | Pain intensity assessed using the Numeric Rating Scale (NRS) |
| Sedation Depth | Every 5 minutes during the procedure, assessed up to 30 minutes. | Sedation level assessed using the Ramsay Sedation Scale. |
| Adverse Events | Perioperatively and through the recovery period, assessed up to 30 minutes. | Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting. |
| Patient and Operator Satisfaction | Immediately after the procedure | Patient and operator satisfaction assessed after completion of the procedure. |
Countries
Turkey (Türkiye)
Outcome results
None listed