Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

Technical University of Munich

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Blockade

Treatments: Drug: Placebo; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT01101139

SIMAR

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Single injection of Sugammadex 0.25 mg/kg

Treatment:

Drug: Sugammadex

Placebo comparator

Placebo Comparator group

Description:

Single injection of Saline 0.9%

Treatment:

Drug: Placebo