The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). (DSA-RCT-1)

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Depth of Hypnosis Monitoring
• Intervention / Treatment: Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris J de Heer, MD; Phone Number: +31107037881; Email: i.deheer@erasmusmc.nl
• Study Contact Backup: Name: Hannah AC Raab, BSc; Email: h.raab@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Iris J de Heer, MD; Phone Number: +31107037881; Email: i.deheer@erasmusmc.nl
      • Contact: Frank Weber, MD, PhD; Phone Number: +31107042521; Email: f.weber@erasmusmc.nl
      • Sub-Investigator: Iris J de Heer, MD
      • Principal Investigator: Frank Weber, MD, PhD
      • Sub-Investigator: Gülhan Karaöz-Bulut, MSc
      • Sub-Investigator: Hannah AC Raab, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Day 1

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Frank Weber, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Density spectral array; Depth of hypnosis; Paediatric anaesthesia
• Other Study ID Numbers: DSA-RCT-1; NL80282.078.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

On reasonable request to the study coordinator data will be shared.

Data of a patient will only be shared with others if the parents explicitly consented to saving their child's data.

• IPD Sharing Time Frame: Data will become available within 12 months after study completion.
• IPD Sharing Access Criteria: Reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No