Sedation
Conditions
Keywords
Sedation, BIS, aEEG, Neonatal Pain and Sedation Scale, neonate, newborn
Brief summary
Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team. The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.
Interventions
DEVICEBispectral Index
The Bispectral-Index is continuously recorded for up to 72 hours in the group of ventilated newborns. Every 15 minutes, a value that was generated by averaging the BIS values of the last 15 minutes will be recorded (automatically calculated by the software of the readout device). The Bispectral-Index is continuously recorded for a minimum of 4 hours in the controls.
DEVICEAmplitude-integrated EEG
A aEEG is recorded once daily for a minimum of four hours in the group of ventilated newborns. In Controls an aEEG is recorded once for a minimum of four hours.
Sponsors
Medical University of Vienna
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation
Exclusion criteria
* congenital malformations * chromosomal aberrations * brain abnormalities * severe cerebral hemorrhage (grade III-IV) * cystic periventricular leukomalacia * infections of the central nervous system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG) | 72 hours | The BIS-Monitoring is continuously recorded for up to 72 hours.A aEEG is recorded once daily for a minimum of four hours. aEEG and BIS are derived continuously for two head electrodes. Every 3-4 hours the N-PASS is evaluated by a nurse and recorded in the patient documentation system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences of the values of the BIS, the aEEG and the sedation scores in the group of mechanically ventilated / sedated newborns and the group of non-ventilated /non-sedated neonates | 72 hours | Comparison of sedation levels between the two groups |
| Relationship between daily doses of sedatives / analgesics and sedation levels | 72 hours | Relationship between daily doses of sedatives / analgesics and sedation levels |
Countries
Austria
Outcome results
None listed