N/A
N=112
The Effect of DSA on Recovery of Anaesthesia in Children
Anesthesia · Depth of Hypnosis Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT05525104 ↗Enrolled (actual)
112
Serious AEs
1.0%
Results posted
Mar 2025
Primary outcome: Primary: The Influence of DSA Monitoring on the Speed of Emergence. — 12; 6 minutes — p=0.041
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Erasmus Medical Center
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Influence of DSA Monitoring on the Speed of Emergence. |
12; 6 | 0.041 sig |
| SECONDARY Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit. |
26.5; 18.5 | 0.066 |
| SECONDARY The Incidence of Postoperative Delirium |
0; 0 | — |
| SECONDARY Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor. |
24; 46; 20; 4; 0; 2 | — |
| SECONDARY Incidence of Recall of Events During the Procedure (Awareness) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The End-tidal Sevoflurane Concentration |
2.3; 1.8 | 0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05525104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.