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Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

2014-08-27 03:14:40 | BioPortfolio

Summary

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

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Neuromuscular Blockade

Intervention

Sugammadex, Placebo

Location

Klinik für Anaesthesiologie Klinikum München rechts der Isar
Munic
Bavaria
Germany
81675

Status

Recruiting

Source

Technische Universität München

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:40-0400

Clinical Trials [506 Associated Clinical Trials listed on BioPortfolio]

Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)

This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced b...

Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery

Our aim was to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatr...

Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)

This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or ve...

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients

This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is p...

PubMed Articles [1869 Associated PubMed Articles listed on BioPortfolio]

Dexamethasone concentration affecting rocuronium-induced neuromuscular blockade and sugammadex reversal in a rat phrenic nerve-hemidiaphragm model: An ex vivo study.

The concentration range of dexamethasone that inhibits neuromuscular blockade (NMB) and sugammadex reversal remains unclear.

Effects of Neostigmine and Sugammadex for Reversal of Neuromuscular Blockade on QT Dispersion Under Propofol Anesthesia: A Randomized Controlled Trial.

Reversal of non-depolarizing neuromuscular blocking agent neostigmine is associated with QT prolongation under general anesthesia. To clarify the effects of neostigmine and sugammadex on hemodynamic s...

Comparison of postoperative coagulation profiles and outcome for sugammadex versus pyridostigmine in 992 living donors after living-donor hepatectomy.

Donor safety is the major concern in living donor liver transplantation, although hepatic resection may be associated with postoperative coagulopathy. Recently, the use of sugammadex has been graduall...

Reversal of Deep Pipecuronium-Induced Neuromuscular Block With Moderate Versus Standard Dose of Sugammadex: A Randomized, Double-Blind, Noninferiority Trial.

Certain surgical interventions may require a deep neuromuscular block (NMB). Reversal of such a block before tracheal extubation is challenging. Because anticholinesterases are ineffective in deep blo...

Profound Bradycardia and Cardiac Arrest After Sugammadex Administration in a Previously Healthy Patient: A Case Report.

We report the case of a 60-year-old man who underwent open radical prostatectomy for prostate adenocarcinoma. He had no known cardiac disease or symptoms other than controlled hypertension and remote ...

Medical and Biotech [MESH] Definitions

The intentional interruption of transmission at the NEUROMUSCULAR JUNCTION by external agents, usually neuromuscular blocking agents. It is distinguished from NERVE BLOCK in which nerve conduction (NEURAL CONDUCTION) is interrupted rather than neuromuscular transmission. Neuromuscular blockade is commonly used to produce MUSCLE RELAXATION as an adjunct to anesthesia during surgery and other medical procedures. It is also often used as an experimental manipulation in basic research. It is not strictly speaking anesthesia but is grouped here with anesthetic techniques. The failure of neuromuscular transmission as a result of pathological processes is not included here.

The use of peripheral nerve stimulation to assess transmission at the NEUROMUSCULAR JUNCTION, especially in the response to anesthetics, such as the intensity of NEUROMUSCULAR BLOCKADE by NEUROMUSCULAR BLOCKING AGENTS.

Various salts of a quaternary ammonium oxime that reconstitute inactivated acetylcholinesterase, especially at the neuromuscular junction, and may cause neuromuscular blockade. They are used as antidotes to organophosphorus poisoning as chlorides, iodides, methanesulfonates (mesylates), or other salts.

Cetyltrimethylammonium compounds that have cationic detergent, antiseptic, and disinfectant activities. They are used in pharmaceuticals, foods, and cosmetics as preservatives; on skin, mucous membranes, etc., as antiseptics or cleansers, and also as emulsifiers. These compounds are toxic when used orally due to neuromuscular blockade.

Bactericidal cationic quaternary ammonium surfactant used as a topical anti-infective agent. It is an ingredient in medicaments, deodorants, mouthwashes, etc., and is used to disinfect apparatus, etc., in the food processing and pharmaceutical industries, in surgery, and also as a preservative. The compound is toxic orally as a result of neuromuscular blockade.

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