Brain functional signature of connected consciousness under general anesthesia

Brain functional signature of connected consciousness under general anesthesia using the isolated forearm technique - IFT_fMRI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002848-24-BE

Enrollment

Registered

2020-01-29

Start date

2020-03-06

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Trade Name: Propolipid Product Name: Propolipid Product Code: SUB10116MIG Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol Other descriptive name: PROPOFOL Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age: 18 - 30 years old - Right-handed - Healthy volunteer: ASA = 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: o Magnetic resonance imaging contraindications (vascular clips, metallic implants) o Women of childbearing age with a suspicion of inadequate contraception o Previous brain trauma o Previous neurosurgical operation o Previous psychiatric disease o Recurrent nightmares o Addiction o Asthma o Vertigo o History of complications after general anesthesia (post-operatory nausea and vomiting, allergy) o Volunteer who participated to previous anesthesia studies conducted by the GIGA-Consciousness unit

Design outcomes

Primary

Measure	Time frame
Main Objective: Our study aims at comparing functional connectivity and effective connectivity in networks that are known to participate in the generation of mental content (such as the Default-Mode network, the Executive Control networks, the Salience network, sensory networks and sensorimotor networks), as well as spatial and temporal dynamics of between brain regions interactions, and network topology. Awake subjects, anesthetized unconscious subjects, and anesthetized subjects who recover connected consciousness after a noxious stimulation will be compared.;Secondary Objective: The secondary objectives of this trial is to compare the cognitive profile and the presence of implicit or explicit memorization between volunteers unconscious anesthetized and volunteers in connected consciousness state under general anesthesia.;Primary end point(s): Identify changes of functional connectivity within and between conscious networks associated with connected consciousness during general anesthesia.;Timepoint(s) of evaluation of this end point: Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state: - awake - unconscious anesthetized - state of connected consciousness under general anesthesia - recovery	—

Measure

Time frame

Main Objective: Our study aims at comparing functional connectivity and effective connectivity in networks that are known to participate in the generation of mental content (such as the Default-Mode network, the Executive Control networks, the Salience network, sensory networks and sensorimotor networks), as well as spatial and temporal dynamics of between brain regions interactions, and network topology. Awake subjects, anesthetized unconscious subjects, and anesthetized subjects who recover connected consciousness after a noxious stimulation will be compared.;Secondary Objective: The secondary objectives of this trial is to compare the cognitive profile and the presence of implicit or explicit memorization between volunteers unconscious anesthetized and volunteers in connected consciousness state under general anesthesia.;Primary end point(s): Identify changes of functional connectivity within and between conscious networks associated with connected consciousness during general anesthesia.;Timepoint(s) of evaluation of this end point: Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state: - awake - unconscious anesthetized - state of connected consciousness under general anesthesia - recovery

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Secondary

Measure	Time frame
Secondary end point(s): Identification of effective connectivity, spatio-temporal interaction and topology changes within and between conscious networks. The evaluation of the cognitive profile will be done through three different scales: - The Dissociative Experiences Scale wich is a validated evaluation of the presence of Dissociative Identity Disorder. - The Tellegen Absorption Scale wich is a measure of absorption. - The 5-Dimensional Altered States of Consciousness Rating Scale which is a reliable measure of alterations from normal waking consciousness. Explicit memorization will be evaluated with the modified Brice questionnaire. Implicit memorization will be evaluated with the two-alternative forced choice signal detection method. ;Timepoint(s) of evaluation of this end point: Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state: - awake - unconscious anesthetized - state of connected consciousness under general anesthesia - recovery The Dissociative Experiences Scale and the Tellegen Absorption Scale will be completed just before general anesthesia. The 5-Dimensional Altered States of Consciousness Rating Scale and the two-alternative forced choice signal detection method will be completed 1 hour after recovery from general anesthesia. The modified Brice questionnaire will be completed 1 hour, 24 hours and 7 days after recovery from general anesthesia.	—

Measure

Time frame

Secondary end point(s): Identification of effective connectivity, spatio-temporal interaction and topology changes within and between conscious networks. The evaluation of the cognitive profile will be done through three different scales: - The Dissociative Experiences Scale wich is a validated evaluation of the presence of Dissociative Identity Disorder. - The Tellegen Absorption Scale wich is a measure of absorption. - The 5-Dimensional Altered States of Consciousness Rating Scale which is a reliable measure of alterations from normal waking consciousness. Explicit memorization will be evaluated with the modified Brice questionnaire. Implicit memorization will be evaluated with the two-alternative forced choice signal detection method. ;Timepoint(s) of evaluation of this end point: Mesure of the end point after acquisition and processing the data of functional magnetic resonance imaging of the volunteers in four different resting state: - awake - unconscious anesthetized - state of connected consciousness under general anesthesia - recovery The Dissociative Experiences Scale and the Tellegen Absorption Scale will be completed just before general anesthesia. The 5-Dimensional Altered States of Consciousness Rating Scale and the two-alternative forced choice signal detection method will be completed 1 hour after recovery from general anesthesia. The modified Brice questionnaire will be completed 1 hour, 24 hours and 7 days after recovery from general anesthesia.

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Countries

Belgium

Contacts

Public ContactVincent Bonhomme

GIGA-Consciousness Thematic Unit, Anesthesia and Intensive Care Laboratory, Liege University

vincent.bonhomme@chuliege.be32043217117

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026