The Effect of DSA on Recovery of Anaesthesia in Children

NCT05525104 | Completed Results DMC

• 2 other identifiers: DSA-RCT-1NL80282.078.22
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Depth of Hypnosis Monitoring

Keywords

Density spectral array; Depth of hypnosis; Paediatric anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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) 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.

  Day 0

Secondary Outcomes (5)

• Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.

  Day 0

• The Incidence of Postoperative Delirium

  Day 0

• Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.

  Day 0

• Incidence of Recall of Events During the Procedure (Awareness)

  Day 0, Day 1, Day 14

• The End-tidal Sevoflurane Concentration

  Day 0

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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)

Interventions

Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) DEVICE

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

Treatment

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Protocol violation
• Data registration failure

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (1)

• de Heer IJ, Raab HAC, de Vries J, Karaoz-Bulut G, Weber F. The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anesthesia in Children. A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):287-293. doi: 10.1111/pan.15065. Epub 2025 Jan 13.

  PMID: 39803999 DERIVED

Limitations and Caveats

The relatively large number of secondary exclusions due to protocol violations in the standard care group is a shortcoming of this study. The target number of 51 participants per study group was not achieved. Because this exclusion due to protocol violation is completely patient independent, confounding due to exclusion for an outcome-related reason is not an issue. So, to identify a treatment effect that would occur under optimal conditions, we choose to perform a per-protocol analysis.

Results Point of Contact

• Title: I.J. de Heer, MD
• Organization: Erasmus Medical center

i.deheer@erasmusmc.nl

+31107040704

Study Officials

• Frank Weber, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and parents will be blinded to the treatment. The outcome assessor will be blinded as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: September 5, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available after data collection has been completed.
• Access Criteria: Reasonable request of fellow researches and only data of patients after explicit consent from parents on the ICF.

Locations

NL (1)