ULTIVA Post Marketing Surveillance

NCT01299584 | Completed Results

• 1 other identifier: 105936
• Study Type: observational
• Target: 775
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With an Adverse Event

  24 hours

• Number of Participants With a Serious Adverse Event

  24 hours

• Number of Participants With the Indicated Unexpected Adverse Event

  24 hours

Study Arms (1)

Remifentanil

Patients administrated remifentanil at the site

Drug: Remifentanil

Interventions

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.

Remifentanil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients requiring general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: September 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 6, 2017
• Results First Posted: April 18, 2011

Record last verified: 2017-06