Monitoring of neuromuscular blockade during general anaesthesia
Phase 1
- Conditions
- We are studying reappearence of nondepolarizing neuromuscular block after it has been antagonized with a combination of neostigmine and glycopyrrolate. We are trying to find the incidence of the phenomenon.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-000561-20-FI
- Lead Sponsor
- Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
AGE 18-65 years
ASA risk class 1-2
Elective surgery reguiring general anaesthesia with estimated duration over 45 min.
Body Mass Index (BMI) <35kg/ m²
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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Disease of central nervous system
Previous injury of central nervous system
Disease affecting peripheral nervous system, or medication affecting peripheral nervous system
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find the incidence of reappearance of nondepolarizing neuromuscular block after reversal with neostigmine.;Secondary Objective: Possible side-effects;Primary end point(s): Incidence of reappearence of nondepolarizing neuromuscular block after reversal with neostigmine.;Timepoint(s) of evaluation of this end point: Lenght of postanaesthesia care
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none