The Effect of DSA on Recovery of Anaesthesia in Children

Not Applicable

Completed

Conditions: Anesthesia
Depth of Hypnosis Monitoring

Interventions: Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)

Registration Number: NCT05525104

Lead Sponsor: Erasmus Medical Center

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)	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

Primary Outcome Measures

Name	Time	Method
The Influence of DSA Monitoring on the Speed of Emergence.	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.	Day 0	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) 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).
Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.	Day 0	Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.
The Incidence of Postoperative Delirium	Day 0	The incidence of postoperative delirium is assessed with the Cornell assessment of postoperative delirium (is defined as a score equal to or greater than 9). The Cornell assessment of postoperative delirium consists of eight questions. The first four questions are scored as follows: 0 equals always, 1 often, 2 sometimes, 3 rarely, 4 never. 1. Does the child make eye contact with the caregiver? 2. Are the child's actions purposeful? 3. Is the child aware of his/her surroundings? 4. Does the child communicatie needs and wants? In these first four questions, a higher score represents a worse outcome. The last four questions are scored as follows: 0 equals never, 1 rarely, 2 sometimes, 3 often and 4 always. 5. Is the child restless? 6. Is the child inconsolable? 7. Is the child underactive - very little movement while awake? 8. Does it take the child a long time to respond to interactions? In these last four questions, a higher score represents a worse outcome.
Incidence of Recall of Events During the Procedure (Awareness)	Day 0, Day 1, Day 14	Awareness is assessed with a modified Brice interview in children of 6 years or older.
The End-tidal Sevoflurane Concentration	Day 0	The mean end-tidal sevoflurane concentration measured during surgical procedure