- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ankara
-
Ankara, Ankara, Tyrkia (Türkiye), 06800
- Rekruttering
- Ankara Bilkent City Hospital
-
Ta kontakt med:
- Mücahid MD Mutlu, Resident
- Telefonnummer: +905078260298
- E-post: mucahid.mutlu@gmail.com
-
Ta kontakt med:
- Mücahid Mutlu
- Telefonnummer: +905078260298
- E-post: mucahid.mutlu@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recovery Time
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemodynamic Stability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Immediately after the procedure
|
Patient and operator satisfaction assessed after completion of the procedure.
|
Immediately after the procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Galleveissykdommer
- Galleveissykdommer
- Neoplasmer
- Kolangitt
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Hydrokarboner
- Cyclohexanes
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Syrer, acyklisk
- Karboksylsyrer
- Piperidines
- Propionater
- Remifentanil
- Ketamin
Andre studie-ID-numre
- TABED-1-25-1188
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Remifentanil
-
Inje UniversityFullførtStrabismusKorea, Republikken
-
University Medical Center GroningenFullførtAnestesi | Hemodynamisk ustabilitet | Interaksjon | Forstyrrelse av oksygentransportNederland
-
Ciusss de L'Est de l'Île de MontréalFullførtIntubasjon; Vanskelig eller mislykketCanada
-
Helse FonnaFullførtHemodynamikk under induksjon av generell anestesi med middels eller lave doser av remifentanil. (RH)Anestesi, general | Anestesi, intravenøs | Hemodynamisk ustabilitetNorge
-
University of ChileRekrutteringAnestesi, intravenøs | Elektroencefalografi | Burst undertrykkelseChile
-
Seoul National University HospitalAjou University School of Medicine; Severance HospitalFullførtSpedbarn, prematureKorea, Republikken
-
Hopital FochFullførtGenerell anestesiFrankrike
-
Seoul National University HospitalHar ikke rekruttert ennå
-
Centre Hospitalier Universitaire de NīmesFullført
-
Erasme University HospitalUniversity of LiegeFullførtOverdosering av intravenøs anestesimiddel