Anaesthesia
Conditions
Keywords
Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Reversal of neuromuscular blockade
Brief summary
According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.
Detailed description
Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.
Interventions
DRUGSugammadex
Sugammadex 200 mg iv, single dose, bolus.
Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* females giving informed consent * age range 18-65 years * elective surgery: gynaecological * general anaesthesia * ASA classification 1 or 2
Exclusion criteria
* pregnancy * body mass index \> 30 * disease affecting CNS * overuse of alcohol * drug abuse * unability to understand, read or use Finnish language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The behaviour of depth of anaesthesia indexes (BIS,SE,RE) | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| The behaviour of electroencephalography | 30 minutes |
Countries
Finland
Outcome results
None listed