Clinical trial NCT01213264: 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)
Official title: Observational Project on the Current Neuromuscular Monitoring Practice (Including Extubation Practice) Via TOF-ratio (Train-of-four) Measurements in Different Types of Surgery After Administration of Neuromuscular Blocking Agents With or Without Reversal (Protocol No. P06556)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
Keywords: neuromuscular blockade, NMBA, sugammadex, Bridion, TOF,
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.


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;
* 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.

Primary outcomes:
measure: Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation
timeFrame: At extubation (approximately <1 to 125 minutes after end of surgery)
measure: Time From End of Surgery (End of Last Stitch) to Extubation
timeFrame: From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)
measure: Type of Surgical Procedure Performed in Study Participants
timeFrame: Day of surgery (Day 1)
measure: Type of NMB-reversal Agent Administered to Study Participants
timeFrame: At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)
Secondary outcomes:
measure: Time From NMB-reversal Agent Administration to Operating Room Dismissal
timeFrame: Post-surgical period (up to approximately 24 hours post-surgery)
measure: Time From NMB-reversal Agent Administration to Recovery Room Dismissal
timeFrame: Post-surgical and recovery period (up to approximately 170 hours post-surgery)
Other outcomes:
Locations:
Study officials:
References: