The effect of sugammadex dose on residual neuromuscular blockade will be investigated, therefore patients suffering from various conditions undergoing surgery in general anaesthesia with muscle relaxation will be included in the study.
Conditions
Sponsors
University of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged 18-65 undergoing general surgery under combined general anaesthesia with neuromuscular blockade 2. ASA (American Society of Anesthesiology) physical status score 1-3 3. BMI (Body-Mass Index) 18,5-25 4. duration of operation over 100 minutes 5. need for intratracheal intubation 6. supine position, at least one arm accessible 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. diseases influencing neuromuscular function (myopathies, significant renal or hepatic insufficiency) 2. drugs influencing neuromuscular function (magnesium, aminoglycosides) 3. gravidity, lactation 4. urgent surgery 5. chronic obstructive pulmonary disease 6. glaucoma 7. difficult airway management possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of the trial is to determine the sugammadex dose, which is suitable for slower (within 10 min.) reversal of residual pipecuronium neuromuscular block.;Primary end point(s): Complete and rapid (within 5 minutes) reversal of neuromuscular blockade (return to TOF 100% during neuromuscular monitoring) after the administration of sugammadex or the placebo drug.;Timepoint(s) of evaluation of this end point: Neuromuscular function is monitored right after extubation and in the next hour continuously. Further monitoring is performed on the day of the operation to assess any possible complications.;Main Objective: The main objective of the trial is to determine the smallest sugammadex dose, which is suitable for the effective, rapid (within 5 min.) and permanent reversal of residual pipecuronium neuromuscular block. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Slow (within 10 minutes) but complete reversal of neuromuscular blockade (return to TOF 100% during neuromuscular monitoring) after the administration of sugammadex or the placebo drug.;Timepoint(s) of evaluation of this end point: Neuromuscular function is monitored right after extubation and in the next hour continuously. Further monitoring is performed on the day of the operation to assess any possible complications. | — |
Countries
Hungary
Contacts
Public ContactDepartmental Office
University of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Therapy
Outcome results
None listed