The Effect of DSA on Recovery of Anaesthesia in Children (DSA-RCT-1)

Erasmus University

Status: Completed

Conditions: Depth of Hypnosis Monitoring; Anesthesia

Treatments: Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT05525104

NL80282.078.22 (Other Identifier)

DSA-RCT-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Control

No Intervention group

Description:

In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.

Treatment

Experimental group

Description:

In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend

Treatment:

Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)