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)
Condition: Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
Study type: Observational

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.
    


Intervention name(s): No neuromuscular blockade (NMB)-reversal agent used; Sugammadex; Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
Intervention type(s): Other; Drug; Drug
Intervention description(s): Participants whose reversal from NMB is spontaneous (no reversal agent used); 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.; 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.
Other intervention name(s): Bridion; SCH 900616
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (18-65 years old) who are undergoing different types of surgical procedures
        (short, intermediate, or long in duration), requiring general anesthesia with a
        non-depolarizing NMBA, with or without NMB reversal.
      
Keywords: neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,