Clinical Trial: Comparison of AMG and EMG to Avoid Residual Paralysis After General Anesthesia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of AMG (Acceleromyography) and EMG (Electromyography) to Avoid Postoperative Residual Paralysis After General Anesthesia
Brief Summary: This study evaluates three different neuromuscular monitoring devices (acceleromyography, one- or three-dimensional, and electromyography) with regard to their precision to detect residual paralysis after injection of neuromuscular blocking agents and recurrence of paralysis after administration of reversal agents in a clinical setting.
Detailed Summary:
Neuromuscular blocking agents (NMBAs) are routinely used as standard part of a modern, balanced anesthesia regime. A residual duration of action exceeding the end of surgery, also called residual neuromuscular paralysis, is a common undesired side effect and increases the risk for postoperative pulmonary complications such as aspiration or pneumonia delaying patients` discharge from the post-anesthesia care unit. To limit the incidence of residual paralysis in daily anesthesia care, quantitative neuromuscular monitoring is recommended after injection of NMBAs. If a residual effect of a NMBA is detected at the end of surgery, reversal agents such as cholinesterase inhibitors, e.g. neostigmine or a selective relaxant binding agent, e.g. sugammadex can be administered. However, if reversal agents are not adequately dosed, the risk for a residual neuromuscular blockade re-occurs. Accordingly, neuromuscular monitoring is also useful to control the action of the administered reversal agents.
Although several techniques of neuromuscular monitoring are established in clinical practice, electromyography (EMG) and acceleromyography (AMG) are the most common quantitative neuromuscular monitoring devices. Electromyography, the gold standard for detecting residual neuromuscular block, is based on measuring summarized spikes of evoked muscle contractions. Acceleromyography measuring the acceleration of evoked muscle contraction is also commercially available and easy to use. This acceleration, however, can be measured both one-dimensionally and three-dimensionally.
This study evaluates the three described neuromuscular monitoring devices with regard to their precision to detect residual paralysis after administration of NMBAs and recurrence of neuromuscular blockade after administration of reversal agents in a clinical setting. We plan
Sponsor: Technische Universität München
Current Primary Outcome: This study evaluates the precision and agreement of TOF-ratios obtained with acceleromyography and electromyography during residual neuromuscular paralysis [ Time Frame: during surgery (2 hours) ]
Original Primary Outcome: Comparison of TOF-ratios obtained with acceleromyography and electromyography [ Time Frame: during surgery (2 hours) ]
Current Secondary Outcome: Incidence of re-occurrence of neuromuscular block after administration of reversal agents measured with acceleromyography and electromyography [ Time Frame: during surgery (2 hours) ]
Original Secondary Outcome: Incidence of postoperative residual neuromuscular blockade measured with acceleromyography and electromyography [ Time Frame: during surgery (2 hours) ]
Information By: Technische Universität München
Dates:
Date Received: April 28, 2014
Date Started: April 2014
Date Completion:
Last Updated: April 27, 2016
Last Verified: April 2016
