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Completed

NCT Number: NCT05525104

The Effect of DSA on Recovery of Anaesthesia in Children

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.

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Key information

Conditions

Anesthesia Depth of Hypnosis Monitoring

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)

Device

This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children's hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children's hospital offers a diversity of diagrams including Density Spectral Array.

The electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration

Primary outcomes

  1. The Influence of DSA Monitoring on the Speed of Emergence.

    Time frame: Day 0

    The speed of emergence is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met (defined as a Steward score ≥ 3)

    The Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake) The speed of emergence is defined as a minimum score of 3, with a minimum score of 1 in each domain.

Secondary outcomes

  1. Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.

    Time frame: Day 0

    The total time is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the recovery room are met (defined as a Steward score =6)

    The Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake).

  2. The Incidence of Postoperative Delirium

    Time frame: Day 0

    The incidence of postoperative delirium is assessed with the Cornell assessment of postoperative delirium (is defined as a score equal to or greater than 9).

    The Cornell assessment of postoperative delirium consists of eight questions. The first four questions are scored as follows: 0 equals always, 1 often, 2 sometimes, 3 rarely, 4 never.

    • Does the child make eye contact with the caregiver?
    • Are the child's actions purposeful?
    • Is the child aware of his/her surroundings?
    • Does the child communicatie needs and wants? In these first four questions, a higher score represents a worse outcome.

    The last four questions are scored as follows: 0 equals never, 1 rarely, 2 sometimes, 3 often and 4 always.

    • Is the child restless?
    • Is the child inconsolable?
    • Is the child underactive - very little movement while awake?
    • Does it take the child a long time to respond to interactions? In these last four questions, a higher score represents a worse outcome.

  3. Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.

    Time frame: Day 0

    Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.

  4. Incidence of Recall of Events During the Procedure (Awareness)

    Time frame: Day 0, Day 1, Day 14

    Awareness is assessed with a modified Brice interview in children of 6 years or older.

  5. The End-tidal Sevoflurane Concentration

    Time frame: Day 0

    The mean end-tidal sevoflurane concentration measured during surgical procedure

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study 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.

Acronym: DSA-RCT-1

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 1, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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