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

8 juni 2026 uppdaterad av: Ankara City Hospital Bilkent

Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

98

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Propofol-Remifentanil
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.
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
Experimentell: Propofol-Ketamine
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.
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Recovery Time
Tidsram: 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.
From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hemodynamic Stability
Tidsram: 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.
Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
Pain Intensity
Tidsram: Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Pain intensity assessed using the Numeric Rating Scale (NRS)
Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Sedation Depth
Tidsram: Every 5 minutes during the procedure, assessed up to 30 minutes.
Sedation level assessed using the Ramsay Sedation Scale.
Every 5 minutes during the procedure, assessed up to 30 minutes.
Adverse Events
Tidsram: 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.
Perioperatively and through the recovery period, assessed up to 30 minutes.
Patient and Operator Satisfaction
Tidsram: Immediately after the procedure
Patient and operator satisfaction assessed after completion of the procedure.
Immediately after the procedure

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2026

Primärt slutförande (Beräknad)

30 maj 2026

Avslutad studie (Beräknad)

10 juni 2026

Studieregistreringsdatum

Först inskickad

12 januari 2026

Först inskickad som uppfyllde QC-kriterierna

8 juni 2026

Första postat (Faktisk)

10 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juni 2026

Senast verifierad

1 januari 2026

Mer information

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