Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia

NCT06346158 | Recruiting FDA Device

• 1 other identifier: 2024-3615
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

general anesthesia; propofol; interindividual variability; prediction; cognitive performance; electroencephalogram

Outcome Measures

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.

  during surgery

Secondary Outcomes (3)

• 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

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

  during surgery

• 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.

  during surgery

Other Outcomes (1)

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

  during surgery

Interventions

Cognitive testing DIAGNOSTIC_TEST

Preoperative cognitive battery test

electroencephalogram DEVICE

Preoperative 24 channel EEG

General anesthesia PROCEDURE

induction of general anesthesia using propofol 1%

High density electroencephalogram DEVICE

preoperative 128-channel electroencephalogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Scheduled for any kind of surgery under general anesthesia.
• Adults

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

Study Sites (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Interventions

Electroencephalography; Anesthesia, General

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Anesthesia; Anesthesia and Analgesia

Study Officials

• Louis Morisson, MD, MSc

  CIUSSS de l'Est de l'Ile de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Morisson, MD, MSc

CONTACT

514-252-3400; louis.morisson@umontreal.ca

Nadia Godin, RN

CONTACT

514-252-3400; nadia.godin.hmr@ssss.gouv.qc.ca

Study Design

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

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 3, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)