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)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery

Treatments: Drug: Sugammadex; Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice; Other: No neuromuscular blockade (NMB)-reversal agent used

Study type: Observational

Funder types: Industry

Identifiers

NCT01213264

P06556

Details and patient eligibility

About

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.

Enrollment: 659 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

659 participants in 3 patient groups

Spontaneous NMB reversal

Description:

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

Treatment:

Other: No neuromuscular blockade (NMB)-reversal agent used

NMB reversal with sugammadex

Description:

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

Treatment:

Drug: Sugammadex

NMB reversal with other agents

Description:

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

Treatment:

Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice