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Clinical Trials/EUCTR2009-013499-29-DE
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

Technische Universität München0 sites0 target enrollmentStarted: August 21, 2009Last updated:
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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