AnesthesiaDSA-RCT-1NCT05525104
The Effect of DSA on Recovery of Anaesthesia in Children
A study testing Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) in people with Anesthesia and Depth of Hypnosis Monitoring, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Anesthesia, Depth of Hypnosis Monitoring
- What is being tested?
- Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Sep 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Secondary exclusion criteria
- Protocol violation
- Data registration failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Anesthesia, Depth of Hypnosis Monitoring
- Being tested
- Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)
- Keywords
- Density spectral array, Depth of hypnosis, Paediatric anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | 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 Receives: Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Influence of DSA Monitoring on the Speed of Emergence.
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.
Measured: Day 0
Secondary outcomes (5)
Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.
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).
Measured: Day 0
The Incidence of Postoperative Delirium
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.
Measured: Day 0
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.
Measured: Day 0
Incidence of Recall of Events During the Procedure (Awareness)
Awareness is assessed with a modified Brice interview in children of 6 years or older.
Measured: Day 0, Day 1, Day 14
The End-tidal Sevoflurane Concentration
The mean end-tidal sevoflurane concentration measured during surgical procedure
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start5 Sep 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Raab, Erasmus Medical Center
- Investigators
- Frank Weber, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525104
- Sponsor's protocol ID
- DSA-RCT-1
- Other IDs
- NL80282.078.22
- Acronym
- DSA-RCT-1
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of a patient will only be shared with other fellow researchers (e.g. in case of follow-up studies) upon reasonable request, on the condition that the child's parent explicitly consented.
Publications
de Heer IJ, Raab HAC, de Vries J, Karaoz-Bulut G, Weber F. The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anesthesia in Children. A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):287-293. doi: 10.1111/pan.15065. Epub 2025 Jan 13.
PubMed 39803999
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05525104
- Acronym / sponsor ID
- DSA-RCT-1 / DSA-RCT-1
- Conditions
- Anesthesia, Depth of Hypnosis Monitoring
- Keywords
- Density spectral array, Depth of hypnosis, Paediatric anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 11 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)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 |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Primary exclusion criteria
- Withdrawal of informed consent
- (Chronic) use of drugs influencing the electroencephalogram
- Use of premedication
- Known intolerance for sevoflurane
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)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 | Device | Treatment |
Primary outcome
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.
5 secondary outcomes
Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.
Time frame: Day 0
The Incidence of Postoperative Delirium
Time frame: Day 0
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
Time frame: Day 0
Incidence of Recall of Events During the Procedure (Awareness)
Time frame: Day 0, Day 1, Day 14
The End-tidal Sevoflurane Concentration
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39803999de Heer IJ, Raab HAC, de Vries J, Karaoz-Bulut G, Weber F. The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anesthesia in Children. A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):287-293. doi: 10.1111/pan.15065. Epub 2025 Jan 13.
- Individual participant dataSharing planned: Yes. Data of a patient will only be shared with other fellow researchers (e.g. in case of follow-up studies) upon reasonable request, on the condition that the child's parent explicitly consented.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Weber, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) in people with Anesthesia and Depth of Hypnosis Monitoring, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Influence of DSA Monitoring on the Speed of Emergence. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.