Dose finding study for sugammadex and/or neostigmine at residual neuromuscular blockade (whereas residual neuromuscular blockade is defined as a TOF of 0.2 in this study). MedDRA version: 9.1 Level: LLT Classification code 10057286 Term: Neuromuscular blockade reversal MedDRA version: 9.1 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal
Conditions
Sponsors
Technische Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dose finding study for sugammadex and/or neostigmine at residual neuromuscular blockade: Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within 2 (mean) but at least five minutes (95 % confidence interval).;Secondary Objective: Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within five minutes (mean) but at least twelve minutes (95 % confidence interval);Primary end point(s): 1. Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within 2 (mean) but at least five minutes (95 % confidence interval). 2. Dose of neostigmine or/and sugammadex reverse residual neuromuscular blockade (TOF 0.2) within five minutes (mean) but at least twelve minutes (95 % confidence interval) | — |
Countries
Germany
Outcome results
None listed