- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01299584
ULTIVA Post Marketing Surveillance
A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.
The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients requiring general anesthesia
Exclusion Criteria:
- According to precautions or warnings on PI, remifentanil should not be administered to the following patients
- Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Remifentanil
Patients administrated remifentanil at the site
|
Basically there is no treatment allocation.
Subjects who would be administered of remifentanil at their physicians' discretion will be enrolled.
Dosage regimen will be recommended according to the prescribing information.
Subjects will be enrolled consecutively.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With an Unexpected Serious Adverse Event
Tidsram: 24 hours
|
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With an Adverse Event
Tidsram: 24 hours
|
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
For a list of all AEs occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
|
24 hours
|
Number of Participants With a Serious Adverse Event
Tidsram: 24 hours
|
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
For a list of all SAEs occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
|
24 hours
|
Number of Participants With the Indicated Unexpected Adverse Event
Tidsram: 24 hours
|
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 105936
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