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)

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Anesthetics; Neuromuscular Blocking Agents

Criteria

Inclusion Criteria

All of the criteria below must be met for a participant to be eligible for study participation.

The prospective participant:

• Is an adult, 18 to 65 years-of-age;

• Is to undergo surgery requiring general anesthesia with non-depolarizing NMBA administration, with or without NMB reversal;

• Meets the inclusion criteria listed on the NMBA label in each country;

• Is willing to participate and sign an informed consent form (ICF).

Exclusion Criteria

Exclusion from the study will be determined by the treating physician. In addition the criteria below should be considered in determining those participants who should be excluded from the study.

The prospective participant:

• Is pregnant or breast feeding;

• Has a neuromuscular disorder;

• Has severe hepatic impairment;

• Has severe renal impairment.