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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06346158
Other study ID # 2024-3615
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information

Verified date March 2024
Source Ciusss de L'Est de l'Île de Montréal
Contact Louis Morisson, MD, MSc
Phone 514-252-3400
Email louis.morisson@umontreal.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

Propofol is the most widely used anesthetic to induce general anesthesia (GA). However, as opposed to volatile anesthesia, propofol concentration monitoring is not directly available in humans. Thus, the use of a pharmacokinetic/pharmacodynamic (PK/PD) model in target-controlled infusion (TCI) is recommended. During infusion, the concentration at effect-site (Ce) is assumed to correlate with the level of hypnosis. However, There is a large variability in propofol requirements in common practice. The variability in propofol requirements is attributed to demographic factors, genetic polymorphism, procedure-related changes, and individual sensitivity. Previous studies have shown that EEG characteristics change with age and cognitive status. Hypothesis : There is a large interindividual variability in patients' sensitivity to propofol which can be precisely modeled using clinical, demographic, and electroencephalographic (EEG) features available prior to induction of general anesthesia. The investigators also hypothesise that this sensitivity to propofol may identify vulnerable brain phenotype related to poor cognitive performance. Specific objectives: Primary: to investigate the variability of Ce propofol at which deep anesthesia (DA) occurs during induction of general anesthesia (CeDA). Secondary: to explore the relationship between demographics, cognitive performance, and EEG variables with the independent CeDA variable. Tertiary: to develop and validate a machine learning algorithm to predict CeDA based on clinical, demographic and EEG features obtained prior the induction of general anesthesia. Methods: This prospective monocentric observational study will include 110 participants of 18 years of age or older scheduled for surgery under general anesthesia. Baseline cognitive performance will be assessed using the Montreal Cognitive Assessment. Induction of GA will be performed using 300ml.h-1 of 1% propofol until DA (Defined as a Patient State Index (PSI) < 30) is observed. The primary endpoint will be the Ce propofol at which deep anesthesia (CeDA) occurs as calculated by the Eleveld PK/PD model for propofol. Preoperative raw EEG waveforms from the SedLine monitor will be used to extract statistical, entropic, and spectral features. High-density EEG (128 channels) will also be recorded in a subsample of 40 patients to extract brain functional connectivity features. These features will be entered in a generalized additive model to predict CeDA. We will also develop and validate a machine learning algorithm to predict CeDA based on these features. Significance/Importance: The results of this study could provide a better understanding of the determinants of the inter-individual variability observed in the pharmacodynamic effect of anesthetic agents. Moreover, the prediction of CeDA may help clinicians in setting the right and safe target in target-controlled infusion of propofol during induction of general anesthesia and further limit the occurrence of deep anesthesia during surgery. Finally, the knowledge of the link between EEG characteristics, sensitivity to anesthetics and cognitive performance may lead to more personalized anesthesia delivery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled for any kind of surgery under general anesthesia. - Adults Exclusion Criteria: - 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, - Anticipated or known difficult ventilation patient, - Body mass index = 35 kg.m-2.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cognitive testing
Preoperative cognitive battery test
Device:
electroencephalogram
Preoperative 24 channel EEG
High density electroencephalogram
preoperative 128-channel electroencephalogram
Procedure:
General anesthesia
induction of general anesthesia using propofol 1%

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ciusss de L'Est de l'Île de Montréal CIUSSS du Nord de l'Ile de Montréal

Outcome

Type Measure Description Time frame Safety issue
Other 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 during surgery
Primary 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. during surgery
Secondary Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia during surgery
Secondary 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 during surgery
Secondary 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 during surgery
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