MedPath

ULTIVA Post Marketing Surveillance

Completed
Conditions
Analgesia
Interventions
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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
RemifentanilRemifentanilPatients administrated remifentanil at the site
Primary Outcome Measures
NameTimeMethod
Number of Participants With an Unexpected Serious Adverse Event24 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
NameTimeMethod
Number of Participants With the Indicated Unexpected Adverse Event24 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 Event24 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 Event24 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.

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