‘Emergence delirium’ (ED) is described as a mental disorder during recovery from general anaesthesia. After the introduction of new inhalation anaesthetics such as sevoflurane, this phenomenon again gained prominence. The specific cause is unknown. Objective of the research
Conditions
Interventions
Pharmaceutical Form:
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: b. Inclusion criteria 1. age between 1,5-6 years old 2. written permission (informed consent) 3. no premedication 4. children who have to undergo a diagnostic MRI scan 5. ASA status 1-2 6. parents who speak Dutch 7. parent present at induction Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. cognitive or emotional development disorder (with exception of ’attention deficit hyperactivity disorder’ (ADHD)) 2. use of active ingredients (AI) which influence the central nervous system (anticonvulsants) 3. those who run the risk of developing malignant hyperthermia 4. hypersensitivity to the inhalation anaesthetic sevoflurane and to propofol 5. need for premedication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary research inquiry being raised concerns anaesthesia related causes: Is it possible that adapting an amount of sevoflurane, from 1 MAC (minimum alveolar concentration) (2,5 vol%) to ½ MAC (1,25 vol%) in an MRI scan can reduce the frequency and gravity of ‘emergence delirium’? ;Secondary Objective: The secondary research inquiry being raised concerns patient related causes: Are parents’ and children’s anxiety at induction, as well as their behaviour, a predictive value for the appearance of ‘ED’? In case a significant ‘ED’ appears, can this lead to an increase of behavioural disorders at 1 day, 1 week and 2 weeks after intervention? ;Primary end point(s): Main study parameters/endpoints: The primary endpoints are the maximum scores on the ‘Pediatric Anesthesia Emergence Delirium Scale’ (PAED) until 1 hour after having stopped the administration of the anaesthetic. We consider a score of >10 on the PAED scale as cut-off for the presence or absence of ED. The secondary endpoints are the time between terminating the administration and the removal of the laryngeal mask airway and the time of reaction (‘responsiveness’) to light or gentle tactile stimulation. | — |
Countries
Netherlands
Outcome results
None listed