'The frequency of behaviour disturbances after different concentration of anaesthetic gases (Sevoflurane) for anaesthesia during M.R.I. examination in children.

'The influence of MAC values and behaviour of a child on emergence delirium after sevoflurane anaesthesia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21231

Enrollment

110

Registered

2011-09-08

Start date

2011-09-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. Anaesthesia, surgery and patient related factors are part of the possible explanations.

Interventions

during the diagnostic research 1 MAC (2,5 vol%) or ½ MAC (1,25 vol%) Sevoflurane is administered.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 1,5-5 years; 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.

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
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 >12 on the PAED scale as cut-off for the presence or absence of ED.	—

Secondary

Measure	Time frame
1. 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; 2. Are parents and childrens anxiety at induction, as well as their behaviour, a predictive value for the appearance of ED?	—

Contacts

Public ContactF. Weber

Erasmus MC - Sophia Dr. Molewaterplein 60

f.weber@erasmusmc.nl+31 (0)10 7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)