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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Observational
• Enrollment (Actual): 775

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects are patients prescribed for Remifentanil by the investigators at the sites based on prescription information in normal clinical practices.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remifentanil; Patients administrated remifentanil at the site	Drug: Remifentanil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With an Unexpected Serious Adverse Event	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With an Adverse Event	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	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	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 105936