Neuromuscular Block Clinical Trial
— SUNDROOfficial title:
Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.5)
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 ß- HCG screen, status post tubal ligation) - Breastfeeding women |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München | Munic | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München |
Germany,
Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2. — View Citation
Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee. — View Citation
Pühringer FK, Rex C, Sielenkämper 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to TOF-ratio 0.9 following the investigational drug | Regular anesthesia time, approximately 1 hour |
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