Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

NCT ID: NCT01101139

Last Updated: 2012-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental

Single injection of Sugammadex 0.25 mg/kg

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex (single intravenous injection 0.25 mg/kg)

Placebo comparator

Single injection of Saline 0.9%

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo: single intravenous injection Saline 0.9%

Interventions

Sugammadex

Sugammadex (single intravenous injection 0.25 mg/kg)

Intervention Type: DRUG

Placebo

Placebo: single intravenous injection Saline 0.9%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manfred Blobner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anaesthesiologie Klinikum München rechts der Isar

Locations

Klinik für Anaesthesiologie Klinikum München rechts der Isar

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 9366929 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18635478 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18648227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1211496 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25586724 (View on PubMed)

Other Identifiers

SIMAR

Identifier Type: -

Identifier Source: org_study_id