Status:
COMPLETED
Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
Lead Sponsor:
Technical University of Munich
Conditions:
Neuromuscular Block
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.
Detailed Description
Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle r...
Eligibility Criteria
Inclusion
- Patients ASA physical status I - III
- Patients between 18 and 64 years
- Patients scheduled for general anesthesia with intubation using rocuronium
- Patients having given informed consent to the study
Exclusion
- Anatomic and functional malformations with expected difficult intubation
- 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 of drugs that interfere with muscle relaxants
- Patients, included in another trial within the last 30 days
- Patients, with legal guidant
- Patients with contraindication towards the use of Sugammadex, neostigmine or glycopyrrolate
- Patients, which have already participated in a sugammadex trial
- Pregnant women (exclusion of pregnancy: postmenopausal status, negative β- HCG screen, status post tubal ligation)
- Breastfeeding women
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00895609
Start Date
March 1 2009
End Date
August 1 2009
Last Update
March 19 2013
Active Locations (1)
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1
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany, 81675