Clinical trial NCT05525104: The Effect of DSA on Recovery of Anaesthesia in Children
Official title: The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anaesthesia in Children Between 6 Months and 12 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Depth of Hypnosis Monitoring
Keywords: Density spectral array
Depth of hypnosis
Paediatric anaesthesia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Influence of DSA Monitoring on the Speed of Emergence.
timeFrame: Day 0
Secondary outcomes:
measure: Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.
timeFrame: Day 0
measure: The Incidence of Postoperative Delirium
timeFrame: Day 0
measure: Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
timeFrame: Day 0
measure: Incidence of Recall of Events During the Procedure (Awareness)
timeFrame: Day 0, Day 1, Day 14
measure: The End-tidal Sevoflurane Concentration
timeFrame: Day 0
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Frank Weber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: