Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

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

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

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Single injection of Sugammadex 0.25 mg/kg	Drug: Sugammadex; Sugammadex (single intravenous injection 0.25 mg/kg)
Placebo Comparator: Placebo comparator; Single injection of Saline 0.9%	Drug: Placebo; Placebo: single intravenous injection Saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Muscle function	Muscle function following the investigational drug

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Manfred Blobner, M.D., Klinik für Anaesthesiologie Klinikum München rechts der Isar

Publications and helpful links

General Publications

• Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
• Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
• Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
• Waud DR, Waud BE. In vitro measurement of margin of safety of neuromuscular transmission. Am J Physiol. 1975 Dec;229(6):1632-4. doi: 10.1152/ajplegacy.1975.229.6.1632.
• Baumuller E, Schaller SJ, Chiquito Lama Y, Frick CG, Bauhofer T, Eikermann M, Fink H, Blobner M. Postoperative impairment of motor function at train-of-four ratio >/=0.9 cannot be improved by sugammadex (1 mg kg-1). Br J Anaesth. 2015 May;114(5):785-93. doi: 10.1093/bja/aeu453. Epub 2015 Jan 13.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: SIMAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No