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- Essai clinique NCT07640243
Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Ankara
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Ankara, Ankara, Turquie (Türkiye), 06800
- Recrutement
- Ankara Bilkent City Hospital
-
Contact:
- Mücahid MD Mutlu, Resident
- Numéro de téléphone: +905078260298
- E-mail: mucahid.mutlu@gmail.com
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Contact:
- Mücahid Mutlu
- Numéro de téléphone: +905078260298
- E-mail: mucahid.mutlu@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recovery Time
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemodynamic Stability
Délai: 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.
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Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
|
|
Pain Intensity
Délai: Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
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Pain intensity assessed using the Numeric Rating Scale (NRS)
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Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
|
|
Sedation Depth
Délai: Every 5 minutes during the procedure, assessed up to 30 minutes.
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Sedation level assessed using the Ramsay Sedation Scale.
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Every 5 minutes during the procedure, assessed up to 30 minutes.
|
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Adverse Events
Délai: Perioperatively and through the recovery period, assessed up to 30 minutes.
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Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.
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Perioperatively and through the recovery period, assessed up to 30 minutes.
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Patient and Operator Satisfaction
Délai: Immediately after the procedure
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Patient and operator satisfaction assessed after completion of the procedure.
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Immediately after the procedure
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Maladies des voies biliaires
- Maladies des voies biliaires
- Tumeurs
- Cholangite
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Hydrocarbures
- Cyclohexanes
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Acides, acyclique
- Acides carboxyliques
- Pipéridines
- Propionates
- Rémifentanil
- Kétamine
Autres numéros d'identification d'étude
- TABED-1-25-1188
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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