N/A
N=659
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)
Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01213264 ↗Enrolled (actual)
659
Serious AEs
1.1%
Results posted
May 2013
Primary outcome: Primary: Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation — 55; 17; 95 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No neuromuscular blockade (NMB)-reversal agent used (Other); Sugammadex (Drug); Other NMB-Reversal Agents Used in Routine Anesthesiology Practice (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation |
55; 17; 95 | — |
| PRIMARY Time From End of Surgery (End of Last Stitch) to Extubation |
12.80; 8.82; 11.76; 9.73; 10.01; 12.20 | — |
| PRIMARY Type of Surgical Procedure Performed in Study Participants |
129; 47; 36; 34; 28; 385 | — |
| PRIMARY Type of NMB-reversal Agent Administered to Study Participants |
327; 177; 155 | — |
| SECONDARY Time From NMB-reversal Agent Administration to Operating Room Dismissal |
15.90; 40.46 | — |
| SECONDARY Time From NMB-reversal Agent Administration to Recovery Room Dismissal |
630.5; 619.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01213264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.