The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anaesthesia in Children Between 6 Months and 12 Years. (DSA-RCT-1)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    112
  • sponsor
    Erasmus Medical Center
Updated on 24 October 2022
analgesia
sevoflurane

Summary

In this randomised, blinded study, we will investigate the influence of DSA on recovery from general anaesthesia. DSA monitoring provides continuous information on depth of hypnosis. Based on DSA monitoring dose adjustments of sevoflurane can be made. We expect that this will lead to a faster speed of emergence and recovery.

Description

Electroencephalographic density spectral array (DSA) is a three dimensional method to display electroencephalogram (EEG) signals consisting of the EEG frequency (y-axis), the power of the EEG signal (colour-coded to be integrated into a two dimensional plot) and the development of the EEG power spectrum over time (x-axis). DSA is routinely used to measure depth of hypnosis (DoH) by a part of the staff members in our department. When DSA is used, dose adjustments of sevoflurane will be made based on monitoring depth of anaesthesia. However, most of our colleague do not use DSA. Dose adjustment is then based on (subjective) clinical surrogate parameters, or in general mostly based on a minimal alveolar concentration of the anaesthetic gas that is used.

Electroencephalographic DSA monitoring provides continuous objective information on DoH and should result in a faster speed of emergence and recovery from general anaesthesia (GA). This will be addressed in a randomised controlled trial.

In patients randomised to the intervention group, the anaesthetic agent sevoflurane will be administered on the basis of objective measures of anaesthetic depth, the typical DSA pattern for GA. We expect a significantly faster speed of emergence and recovery in the intervention group based on clinical experience. The Narcotrend monitor is validated for use in paediatric patients. There are thus no additional risk factors apart from those, which are inherent with general anaesthesia. Patient randomised to the control group will receive standard treatment, that is delivery of sevoflurane based on a MAC of 0.9 respectively an end tidal sevoflurane concentration of 2.3%. A non-invasive therapeutical intervention (DSA based conduct of GA) should result in the advantage of faster recovery, without any additional risk factor.

Details
Condition Anesthesia, Depth of Hypnosis Monitoring
Treatment Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)
Clinical Study IdentifierNCT05525104
SponsorErasmus Medical Center
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent of parents/guardians
Age ≥6 months and ≤12 years
Surgical procedure requiring GA supplemented with caudal analgesia
Ability of the parents/guardians to communicate in Dutch

Exclusion Criteria

Primary exclusion criteria
Withdrawal of informed consent
(Chronic) use of drugs influencing the electroencephalogram
Use of premedication
Known intolerance for sevoflurane
Parents/guardians unable to communicate in Dutch
Secondary exclusion criteria
Protocol violation
Data registration failure
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