An interventional study of Remifentanil and Ketamine in Fragility, Biliary Obstruction and Cholangitis, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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.
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.
82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.
This study's planned enrollment of 98 is close to the median of 100 across 52 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.
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
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.
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.
Sedation Depth
Sedation level assessed using the Ramsay Sedation Scale.
Time frame: Every 5 minutes during the procedure, assessed up to 30 minutes.
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.
Patient and Operator Satisfaction
Patient and operator satisfaction assessed after completion of the procedure.
Time frame: Immediately after the procedure
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for May 2026, 3 months after the start.
Of 21 interventional studies with no phase under Cholangitis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 68. This study's planned 3 months is below that.
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Studies of the drugs tested here: Remifentanil · Ketamine
Ankara City Hospital Bilkent →