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Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556)

NCT01213264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 659

Last updated 2015-03-17

Study results available
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Summary

The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four \[TOF\] value) during surgery, in countries of Central and Eastern Europe, Middle East and Africa (CEE/EEMEA countries). Secondarily the study will observe, for which surgical procedures neuromuscular blocking agents (NMBAs), and reversal agents to such, are used. This study is a non-interventional clinical trial, and administration of NMBAs, and respective reversal agents, (as well as all drugs used during anesthesia) will be done in accordance with routine anesthesiology practice, and labeling guidelines. Neuromuscular transmission will be monitored according to routine anesthesiology practice by means of acceleromyography. The assignment of the participant to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Conditions

  • Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery

Interventions

OTHER

No neuromuscular blockade (NMB)-reversal agent used

Participants whose reversal from NMB is spontaneous (no reversal agent used)

DRUG

Sugammadex

Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice. As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive the NMB-reversal agent sugammadex, administered according to the local clinical practice and drug product labeling.

DRUG

Other NMB-Reversal Agents Used in Routine Anesthesiology Practice

Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice. As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive any NMB-reversal agent other than sugammadex, and represents multiple drugs whose use and administration may vary according to local clinical practice, product availability and product labeling.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213264 on ClinicalTrials.gov