Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

Phase 4

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Placebo; Drug: Sugammadex

• Registration Number: NCT01101139
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator	Placebo	Single injection of Saline 0.9%
Experimental	Sugammadex	Single injection of Sugammadex 0.25 mg/kg

Primary Outcome Measures

Name	Time	Method
Muscle function		Muscle function following the investigational drug

Trial Locations

Locations (1)

Klinik für Anaesthesiologie Klinikum München rechts der Isar; 🇩🇪 Munic, Bavaria, Germany