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Completed

NCT Number: NCT01101139

Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik für Anaesthesiologie Klinikum München rechts der Isar

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Sugammadex (single intravenous injection 0.25 mg/kg)

Placebo

Drug

Placebo: single intravenous injection Saline 0.9%

Primary outcomes

  1. Muscle function

    Muscle function following the investigational drug

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2010
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.