Sellainen leikkaushoitoa vaativa sairaus, jossa leikkauksen arvioitu kesto on vähintään 30 min
Conditions
Interventions
Trade Name: Bridion
Pharmaceutical Form: Injection*
INN or Proposed INN: SUGAMMADEX
CAS Number: 343306-71-8
Trade Name: Glycostigmin
Pharmaceutical Form: Injection*
INN or Proposed INN: NEOSTIGMINE M
Sponsors
Klaus Olkkola
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects belonging to ASA class 1-4. 2. Admitted to hospital for surgical procedures with an estimated at least 30 min duration of general anaesthesia. 3. Informed written consent for participation in the 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. Patients with muscular dystrophies, myopathy or cerebral palsy. 2. A previous history of intolerance to the study drugs or to related compounds and additives. 3. Clinically significant renal or hepatic dysfunction. 4. Marked ventilatory impairment due to underlying respiratory disease. 5. Raised intracranial pressure. 6. Patients younger than 18 and older than 70 years. 7. Body mass index greater than 32.5 (Appendix 1). 8. Patients on concomitant medication known to significantly affect the neuromuscular transmission. 9. Pregnancy or lactation. Pregnancy and lactation will be excluded by anamnestic information. 10. Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Selvittää lihasvoiman toipumisen nopeutta yleisanestesian lopussa annettavien lihasrelaksanttien antagonistien annon jälkeen. Hypoteesina on, että sugammadeksin annon jälkeen TOF-suhde palautuu nopeammin tasolle 0.9 kuin neostigmiinin annon jälkeen. Aika lasketaan antagonistien antohetkestä. Antagonistit annetaan sillä hetkellä, jolloin TOF-stimulaatiossa tuntuu kaksi nykäystä.;Secondary Objective: ;Primary end point(s): Primary endpoint is the time when a TOF-ratio has returned to 0.90 after reversal. | — |
Countries
Finland
Outcome results
None listed