Clinical safety of neostigmine or sugammadex to reverse rocuronium-induced neuromuscular blockRokuronilla aikaansaadun lihasrelaksaation kumoaminen neostigmiinilla tai sugammadeksilla: kliininen turvallisuus
- Conditions
- Sellainen leikkaushoitoa vaativa sairaus, jossa leikkauksen arvioitu kesto on vähintään 30 min
- Registration Number
- EUCTR2009-013537-22-FI
- Lead Sponsor
- Klaus Olkkola
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method