Trial Outcomes & Findings for The Effect of DSA on Recovery of Anaesthesia in Children (NCT NCT05525104)
NCT ID: NCT05525104
Last Updated: 2025-03-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Day 0
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Control
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
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
44
|
52
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
| Measure |
Control
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
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
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
|
|---|---|---|
|
Overall Study
Failed caudal analgesia
|
1
|
3
|
|
Overall Study
Premedication needed
|
0
|
1
|
|
Overall Study
Protocol Violation
|
10
|
0
|
|
Overall Study
Cancelled operation
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.2 years
STANDARD_DEVIATION 2.6 • n=44 Participants
|
2.4 years
STANDARD_DEVIATION 2.7 • n=52 Participants
|
2.3 years
STANDARD_DEVIATION 2.7 • n=96 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=44 Participants
|
4 Participants
n=52 Participants
|
8 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=44 Participants
|
48 Participants
n=52 Participants
|
88 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
13.6 kilogram
STANDARD_DEVIATION 6.3 • n=44 Participants
|
13.8 kilogram
STANDARD_DEVIATION 6.6 • n=52 Participants
|
13.7 kilogram
STANDARD_DEVIATION 6.4 • n=96 Participants
|
|
ASA-score
1
|
37 Participants
n=44 Participants
|
46 Participants
n=52 Participants
|
83 Participants
n=96 Participants
|
|
ASA-score
2
|
6 Participants
n=44 Participants
|
6 Participants
n=52 Participants
|
12 Participants
n=96 Participants
|
|
ASA-score
3
|
1 Participants
n=44 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=96 Participants
|
|
Type of surgery
Orchidopexy
|
18 Participants
n=44 Participants
|
15 Participants
n=52 Participants
|
33 Participants
n=96 Participants
|
|
Type of surgery
Inguinal hernia repair
|
9 Participants
n=44 Participants
|
8 Participants
n=52 Participants
|
17 Participants
n=96 Participants
|
|
Type of surgery
Urethral valves repair
|
0 Participants
n=44 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=96 Participants
|
|
Type of surgery
Hypospadias correction
|
9 Participants
n=44 Participants
|
13 Participants
n=52 Participants
|
22 Participants
n=96 Participants
|
|
Type of surgery
Cystoscopy/Sachse or meatotomy
|
3 Participants
n=44 Participants
|
11 Participants
n=52 Participants
|
14 Participants
n=96 Participants
|
|
Type of surgery
Other urological
|
4 Participants
n=44 Participants
|
4 Participants
n=52 Participants
|
8 Participants
n=96 Participants
|
|
Type of surgery
Orthopedic surgery
|
1 Participants
n=44 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=96 Participants
|
|
Duration of general anesthesia
|
83.7 minutes
STANDARD_DEVIATION 39.1 • n=44 Participants
|
69.4 minutes
STANDARD_DEVIATION 37.2 • n=52 Participants
|
75.5 minutes
STANDARD_DEVIATION 36.8 • n=96 Participants
|
PRIMARY outcome
Timeframe: Day 0The 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.
Outcome measures
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
|---|---|---|
|
The Influence of DSA Monitoring on the Speed of Emergence.
|
12 minutes
Interval 6.0 to 24.3
|
6 minutes
Interval 4.0 to 16.8
|
SECONDARY outcome
Timeframe: Day 0The 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).
Outcome measures
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
|---|---|---|
|
Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.
|
26.5 minutes
Interval 12.3 to 40.5
|
18.5 minutes
Interval 7.0 to 32.5
|
SECONDARY outcome
Timeframe: Day 0The 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. 1. Does the child make eye contact with the caregiver? 2. Are the child's actions purposeful? 3. Is the child aware of his/her surroundings? 4. 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. 5. Is the child restless? 6. Is the child inconsolable? 7. Is the child underactive - very little movement while awake? 8. Does it take the child a long time to respond to interactions? In these last four questions, a higher score represents a worse outcome.
Outcome measures
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
|---|---|---|
|
The Incidence of Postoperative Delirium
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.
Outcome measures
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
|---|---|---|
|
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
DSA pattern representing general anesthesia
|
24 Participants
|
46 Participants
|
|
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
DSA pattern representing too deep anesthesia
|
20 Participants
|
4 Participants
|
|
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.
DSA pattern representing lighter anesthesia
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 1, Day 14Population: Interviews only conducted in children ≥6 years
Awareness is assessed with a modified Brice interview in children of 6 years or older.
Outcome measures
| Measure |
Control
n=6 Participants
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
n=7 Participants
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
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
|
|---|---|---|
|
Incidence of Recall of Events During the Procedure (Awareness)
Day 14
|
0 participants
|
0 participants
|
|
Incidence of Recall of Events During the Procedure (Awareness)
Day 0
|
0 participants
|
0 participants
|
|
Incidence of Recall of Events During the Procedure (Awareness)
Day 1
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 0The mean end-tidal sevoflurane concentration measured during surgical procedure
Outcome measures
| Measure |
Control
n=44 Participants
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
n=52 Participants
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
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
|
|---|---|---|
|
The End-tidal Sevoflurane Concentration
|
2.3 percentage sevoflurane of exhaled air
Standard Deviation 0.1
|
1.8 percentage sevoflurane of exhaled air
Standard Deviation 0.34
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=44 participants at risk
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
n=52 participants at risk
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
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
|
|---|---|---|
|
Infections and infestations
Prolonged hospitalisation
|
0.00%
0/44 • Adverse event data were collected for the entire study period: until the patiënt was discharged (on average 3-6 hours after anesthesia) or until the last Brice interview was conducted if the patient was 6 years or older (2 weeks after anesthesia).
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected for the entire study period: until the patiënt was discharged (on average 3-6 hours after anesthesia) or until the last Brice interview was conducted if the patient was 6 years or older (2 weeks after anesthesia).
|
Other adverse events
| Measure |
Control
n=44 participants at risk
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
n=52 participants at risk
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
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
|
|---|---|---|
|
Cardiac disorders
Decrease in blood pressure (-2 SD)
|
6.8%
3/44 • Number of events 3 • Adverse event data were collected for the entire study period: until the patiënt was discharged (on average 3-6 hours after anesthesia) or until the last Brice interview was conducted if the patient was 6 years or older (2 weeks after anesthesia).
|
0.00%
0/52 • Adverse event data were collected for the entire study period: until the patiënt was discharged (on average 3-6 hours after anesthesia) or until the last Brice interview was conducted if the patient was 6 years or older (2 weeks after anesthesia).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place