Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

Study Overview
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Brief Summary
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This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.

Detailed Description
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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.

Official Title
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Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical stauts II - III Age: 18 - 65 years Patients scheduled for general anesthesia with intubation using rocuronium Patients have given informed consent to the study Patients receiving the investigational drug within 15 minutes after neuromuscular recovery to a TOF 0.9 Sufficient knowledge of the German language Exclusion Criteria: known or suspected neuromuscular disease significant hepatic or renal dysfunction known or suspected history or family history of disposition to malignant hyperthermia known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia Use o drugs that interfere with sugammadex Patients included in another trial within the last 30 days Patients with legal guidant Patients with contradiction towards the use of Sugammadex Pregnant women Breast-feeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Single injection of Sugammadex 0.25 mg/kg | Drug: Sugammadex<br>* Sugammadex (single intravenous injection 0.25 mg/kg)<br>|
| Placebo Comparator: Placebo comparator<br>Single injection of Saline 0.9% | Drug: Placebo<br>* Placebo: single intravenous injection Saline 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Muscle function following the investigational drug |  |