ULTIVA Post Marketing Surveillance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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.

Primary outcomes

Number of Participants With an Unexpected Serious Adverse Event

Time frame: 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 outcomes

Number of Participants With an Adverse Event

Time frame: 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

Time frame: 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.
Number of Participants With the Indicated Unexpected Adverse Event

Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Feb 18, 2011
Registry last updated: Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed