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Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia

ConditionAnesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.

The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by

* Electroencephalographic (EEG) features available prior to induction of anesthesia * Cognitive performance * Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for any kind of surgery under general anesthesia.

Adults

Disqualifiers

Inability to communicate in French or English,

Known allergy or intolerance or other medical condition that precludes the use of prescribed general anesthesia protocol for this study,

Patients requiring rapid sequence induction,

Anticipated or known difficult intubation patient,

Trial population

Adults' patients scheduled for any kind of surgery in our institution

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive testing

    Diagnostic test

    Preoperative cognitive battery test

  • electroencephalogram

    Device

    Preoperative 24 channel EEG

  • High density electroencephalogram

    Device

    preoperative 128-channel electroencephalogram

  • General anesthesia

    Procedure/Surgery

    induction of general anesthesia using propofol 1%

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Concentration at the effect-site propofol associated with deep anesthesia (CeDA)

Concentration at the effect-site propofol as calculated by the Eleveld model required to reach a Bispectral index \< 45 during induction of general anesthesia in micrograms per mL.

Time frame
during surgery

Secondary outcomes

1

Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia

Time frame
during surgery
2

Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia

A generalized additive model will be constructed based on features associated with the Concentration at the effect-site propofol associated with deep anesthesia

Time frame
during surgery
3

Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia.

We will developp a machine learning model to predict the Concentration at the effect-site propofol associated with deep anesthesia on a separate database and validate the model on the patients of the present study

Time frame
during surgery

Other outcomes

1

Concentration at the effect-site propofol associated with loss of consciousness (CeLOC)

Concentration at the effect-site propofol as calculated by the Eleveld model required for loss of consciousness during induction of general anesthesia

Time frame
during surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Collaborator

Source ClinicalTrials.gov
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