The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).

Anesthesia Clinical Trial

— DSA-RCT-1  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525104
• Other study ID #: DSA-RCT-1
• Secondary ID: NL80282.078.22
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Iris J de Heer, MD
• Phone: +31107037881
• Email: i.deheer[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We expect that this will lead to a faster speed of emergence and recovery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• 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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		Day 1
Primary	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)	Day 1
Secondary	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)	Day 1
Secondary	The incidence of postoperative delirium	The incidence of postoperative delirium is assessed with the Cornell assessment of postoperative delirium (delirium is defined as a score equal to or greater than 9)	Day 1
Secondary	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.	Day 1
Secondary	Incidence of recall of events during the procedure (awareness)	Awareness is assessed with a modified Brice interview in children of 6 years or older.	Day 1, Day 2, Day 14