Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children

Anesthesia Clinical Trial

— SPECTRAL-PED  

Official title:

Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020599
• Other study ID #: APHP230375
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dan Longrois, MD, PhD
• Phone: 01 47 60 61 35
• Email: dan.longrois[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using data from a prospective cohort of children receiving general anaesthesia for surgery, this project will collect pharmacological correlates (doses and timing of administration of anaesthetic drugs) and clinical correlates (stimulations including nociceptive stimulation, possible responses such as movement/resumption of spontaneous ventilation during maintenance of anaesthesia/tachycardia/high blood pressure) of patients during the three phases of anesthesia (induction, maintenance, emergence).

Description:

The usual practice of general anesthesia in children is based on the prescription of anesthetic drugs with doses adapted to weight and neurological examination focusing on the functions of the brainstem. Each patient has a specific sensitivity to anesthetic drugs (inter-individual pharmacokinetic and pharmacodynamic variability).

This inter-individual variability is likely to cause anesthesia that is too deep or, conversely, too light, which can be difficult to anticipate and can cause complications, particularly hemodynamic and neurocognitive. Because of the pharmacokinetics of anesthetic drugs, once an overdose is present, it will be relatively prolonged (several minutes). This is the correction of overdose.

In adults, monitoring of anesthesia adequacy is performed by EEG signal analysis (mainly BIS (Bispectral Index) monitor, Medtronic, Dublin, Ireland). This practice is not very common in children.

Since 2020, an EEG monitor (Sedline, Masimo, Irvine, California, USA) allows the estimation of the adequacy of anesthesia in children based on an EEG model (spectral density matrix; double spectrum delta and alpha during the maintenance phase of anesthesia).

Nevertheless, the pharmacological correlates (doses and delays in reaching the peak of the effect of drugs) as well as the clinical correlates (loss of verbal contact at induction, responses to nociceptive stimuli during the maintenance of anesthesia, return of brainstem functions in the emerging phase) associated with this double delta/alpha spectrum are not described. In addition, monitor EEG analysis tools cannot correctly describe (in spectral density matrix) the induction and emergence (awakening) phases of general anesthesia.

Questions remain about the potentially deleterious effects of general anesthesia in children, especially in children under one year of age. To the extent that general anesthesia is necessary for the performance of the surgical procedure, it is essential to have tools (cortical EEG) that make it possible to adjust the doses of anesthetic drugs to adapt to inter-individual variability. In children, the use of EEG for estimating the adequacy of anaesthesia remains incomplete and imperfect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• 1 year < age < 18 years

• Weight> 10 kg

• Child receiving general anesthesia for any scheduled surgical procedure (dentistry and ENT) at Louis Mourier Hospital

• Information for holders of parental authority

Exclusion Criteria:

• Child with known autism disorder

• Refusal of parental authority holders to participate or refusal of the child

• Participation in other intervention research

• Not affiliated to a social security system

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacological correlates (doses and timing of administration of anaesthetic drugs) of patients during the three phases of anaesthesia (induction/maintenance/emergence).	The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).	6 months
Primary	Clinical correlates (stimulations including nociceptive stimulation, possible responses such as movement/resumption of spontaneous ventilation during maintenance of anaesthesia/tachycardia/hypertension) of patients during the three phases of anaesthesia.	The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).	6 months
Secondary	The calculation of the delta-alpha ratio to help the development of mathematical tools to quantify delta-alpha spectra images on the spectral density matrix during the maintenance phase of anesthesia		6 months
Secondary	Intra-individual correlation of sensitivity between the different phases of anesthesia (induction-maintenance-emergence)	This is to test the hypothesis that a patient identified as sensitive during the induction phase (time required to move from a delta trace with superimposed alpha to a trace with exclusive delta waves) will also be sensitive (will need lower doses/concentrations of hypnotics) to have a double delta-alpha spectrum during the maintenance phase of anesthesia. If this interindividual sensitivity persists, the patient will need to emerge from anesthesia (persistence of fast waves) at lower concentrations of hypnotics compared to less sensitive patients.	6 months
Secondary	Sensitivity and specificity of a typical EEG profile (persistent beta/gamma waves) to help predicting extubation against currently used clinical and "scientific" criteria.		6 months