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The influence of electroencephalographic density spectral array guidance of sevoflurane administration on recovery from general anaesthesia in children between 6 months and 12 years.

The influence of electroencephalographic density spectral array guidance of sevoflurane administration on recovery from general anaesthesia in children between 6 months and 12 years. - The effect of DSA on recovery of anaesthesia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56659
Enrollment
112
Registered
2022-07-29
Start date
2022-09-05
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

n.v.t.

Interventions

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

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
No minimum to 11 Years

Inclusion criteria

Inclusion criteria: Written informed consent of the parents/legal representatives Age > 6 months and

Exclusion criteria

Exclusion criteria: Withdrawal of informed consent (Chronic) use of drugs influencing the electroencephalogram Use of premedication Known intolerance for sevoflurane Parents/legal guardians unable to communicate in Dutch

Design outcomes

Primary

MeasureTime frame
the influence of density spectral array monitoring with the Narcotrend monitor on the speed of emergence from general anaesthesia with sevoflurane. 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).

Secondary

MeasureTime frame
Total time from discontinuation of anaesthetic drug delivery until discharge from the post anaesthesia care unit. The difference in intra-operative blood pressure between the intervention group and the control group. Differences of depth of hypnosis during the procedure, as measured by the Narcotrend monitorTM. The incidence of postoperative delirium by the Cornell Assessment of Postoperative Delirium (CAPD) score Incidence of recall of events during the procedure (awareness) Adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)