N/A
Completed N=775
ULTIVA Post Marketing Surveillance
Analgesia
Source: ClinicalTrials.gov NCT01299584 ↗
Enrolled (actual)
775
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With an Unexpected Serious Adverse Event — 0; 766 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Unexpected Serious Adverse Event |
0; 766 | — |
| SECONDARY Number of Participants With an Adverse Event |
187 | — |
| SECONDARY Number of Participants With a Serious Adverse Event |
— | — |
| SECONDARY Number of Participants With the Indicated Unexpected Adverse Event |
1; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01299584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.