Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01101139
First received: April 8, 2010
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Neuromuscular Blockade
Drug: Sugammadex
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Muscle function [ Designated as safety issue: No ]
    Muscle function following the investigational drug


Enrollment: 300
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101139

Locations
Germany
Klinik für Anaesthesiologie Klinikum München rechts der Isar
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Manfred Blobner, M.D. Klinik für Anaesthesiologie Klinikum München rechts der Isar