Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)|
- Muscle function [ Designated as safety issue: No ]Muscle function following the investigational drug
|Study Start Date:||April 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Single injection of Sugammadex 0.25 mg/kg
Sugammadex (single intravenous injection 0.25 mg/kg)
Placebo Comparator: Placebo comparator
Single injection of Saline 0.9%
Placebo: single intravenous injection Saline 0.9%
Muscle relaxants are an integral part of today's anesthesia. They improve intubating conditions and reduce doses of other substances needed for general anesthesia. For ensuring patient safety, neuromuscular function is monitored during general anesthesia. The latter one is only terminated, when neuromuscular monitoring shows an objective normal value. Despite this accurate surveillance, a lot of patients complain about subjectively uncomfortable muscle weakness in the recovery room. A possible explanation for this ostensive contradiction can be the variable "margin of safety" of neuromuscluar transmission in different muscle groups. Waud et al describe this phenomenon, as the fact, that neuromuscular transmission is only clinically detectable, when a certain number of post-synaptic receptors is not blocked. The necessary fraction of free receptors differs a lot between the muscle groups (15-50%). As neuromuscular monitoring only measures one muscle group exemplarily, and a clinically non-detectable number of post-synaptic receptors can be blocked shortly after anesthesia, the subjective muscle weakness of patients could need treatment.
Sugammadex can encapsulate steroid-typ muscle relaxants within 2 to 5 minutes. After applying a sufficiently high dose, also those receptors will be free that elude neuromuscular monitoring. This constellation brings up the interesting problem to quantify the possible effect on patients' subjective muscle weakness.
This study is designed to investigate, if the application of sugammadex improves muscle function and consequently well-being of patients, that have been extubated according to clinical standard.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101139
|Klinik für Anaesthesiologie Klinikum München rechts der Isar|
|Munic, Bavaria, Germany, 81675|
|Principal Investigator:||Manfred Blobner, M.D.||Klinik für Anaesthesiologie Klinikum München rechts der Isar|