EUCTR2009-013499-29-DEActive, not recruitingPhase 1
Dosisfindungsstudie für Sugammadex und Neostigmin zur Reversierung einer geringen neuromuskulären Restblockade (train of four ratio 0,2) [Sugammadex and Neostigmine dose finding study for reversal of residual neuromuscular blockade at a train of four ratio of 0.2] - SUNDRO20
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. ASA I to III
- •2. patients older than 18 years
- •3. patients where general anesthesia with rocuronium for intubation is planned
- •4. patients which signed confirmed consent for this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. anatomic or functional malformation where difficult intubation is expected
- •2. known or assumed neuromuscular disease
- •3. significant hepatic or renal dysfunction
- •4. known or assumed history or family history of malignand hyperthermia
- •5. known or assumed allergy against sugammadex, anestehtics, muscle relaxans or other medication used for general anesthesia
- •6. intake of any medication which interacts with muscle relaxans
- •7. patients which have been in another clinical study in the past 30 days
- •8. patiens who are supervised in medical decisions
- •9. patient who have contraindications for sugammadex, neostigmine or glycopyrolate
- •10. patients who have been enrolled at another sugammadex study
- •11. pregnant females
- •12. females who are breast feeding
Investigators
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