- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Ankara
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Ankara, Ankara, Turchia (Türkiye), 06800
- Reclutamento
- Ankara Bilkent City Hospital
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Contatto:
- Mücahid MD Mutlu, Resident
- Numero di telefono: +905078260298
- Email: mucahid.mutlu@gmail.com
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Contatto:
- Mücahid Mutlu
- Numero di telefono: +905078260298
- Email: mucahid.mutlu@gmail.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recovery Time
Lasso di tempo: 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.
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From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hemodynamic Stability
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Sedation Depth
Lasso di tempo: 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.
|
|
Adverse Events
Lasso di tempo: 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
Lasso di tempo: Immediately after the procedure
|
Patient and operator satisfaction assessed after completion of the procedure.
|
Immediately after the procedure
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Malattie delle vie biliari
- Malattie del dotto biliare
- Neoplasie
- Colangite
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Idrocarburi
- Ciclohexanes
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Acidi, aciclici
- Acidi carbossilici
- Piperidine
- Propionati
- Remifentanil
- Ketamina
Altri numeri di identificazione dello studio
- TABED-1-25-1188
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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