ULTIVA Post Marketing Surveillance
- Registration Number
- NCT01299584
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 775
- Patients requiring general anesthesia
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Remifentanil Remifentanil Patients administrated remifentanil at the site
- Primary Outcome Measures
Name Time Method Number of Participants With an Unexpected Serious Adverse Event 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With the Indicated Unexpected Adverse Event 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.
Number of Participants With an Adverse Event 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.
Number of Participants With a Serious Adverse Event 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.