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

NCT06020599 | Recruiting

• 1 other identifier: APHP230375
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anesthesia

Keywords

anesthesia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• 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

• Intra-individual correlation of sensitivity between the different phases of anesthesia (induction-maintenance-emergence)

  6 months

• 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

Study Arms (1)

Children who need general anesthesia for surgery

Children who need general anesthesia for surgery (ENT, dentistry) at Louis Mourier Hospital.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring general anesthesia for surgery (ENT, dentistry) at Louis Mourier Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Louis Mourier

Colombes, 92025, France

RECRUITING

Study Officials

• Dan Longrois, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Longrois, MD, PhD

CONTACT

01 47 60 61 35; dan.longrois@aphp.fr

Christian De Tymowski, MD

CONTACT

01 47 60 61 35; christian.detymowski@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 31, 2023
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)