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)

NCT ID: NCT01213264

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 659 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-02-29

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Spontaneous NMB reversal

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

No neuromuscular blockade (NMB)-reversal agent used

Intervention Type: OTHER

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

NMB reversal with sugammadex

Participants who are administered sugammadex for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines

Sugammadex

Intervention Type: DRUG

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.

NMB reversal with other agents

Participants who are administered any other agent (other than sugammadex) for NMB reversal in accordance with routine anesthesiology practice, and labeling guidelines

Other NMB-Reversal Agents Used in Routine Anesthesiology Practice

Intervention Type: DRUG

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.

Interventions

No neuromuscular blockade (NMB)-reversal agent used

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

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Bridion; SCH 900616

Eligibility 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P06556

Identifier Type: -

Identifier Source: org_study_id