NCT05879731

Brief Summary

The goal of this preliminary prospective and observational study is to use hd-EEG (high density electroencephalogram) to investigate how functional and network markers of consciousness are associated to nociception during general anesthesia. More specifically, the aim of this study is to characterize whole-brain functional connectivity and network changes induced by noxious stimulation, and adapt these findings to a clinically-applicable EEG (electroencephalogram) montage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

March 30, 2023

Last Update Submit

June 12, 2023

Conditions

Nociceptive PainAnesthesia

Keywords

anesthesiaconsciousnessnociceptionfunctional connectivityEEG-hd

Outcome Measures

Primary Outcomes (4)

  • Awake (Baseline resting-state)

    EEG with eyes closed will be performed before induction, with a 128-channel EEG saline net (measured in microvolts - mV). Investigators will construct functional connectivity networks using the amplitude envelope correlation (AEC), weighted phase lag index (wPLI) and directed phase lag index (dPLI). This will be conducted in delta (0.5-4Hz), theta (4-7 Hz), alpha (8-13 Hz) and beta (14-30 Hz) frequency bands for all pairwise combinations of electrode channels on 10-sec windows. From wPLI and AEC matrices, investigators will calculate: * Global functional connectivity * Binary smallworldness * Clustering coefficient * Modularity * Characteristic Path Length * Global Efficiency * Hub posteriority ratio dPLI will be used to assess feedback dominance index. Investigators will also calculate: * Lempel-Ziv complexity * Edge-of-chaos criticality * Proximity to criticality * Pair correlation function * Order parameter

    5 minutes

  • Pre-Stimulation (Resting-state)

    EEG will be performed after induction, with a 128-channel EEG saline net (measured in microvolts - mV). Investigators will construct functional connectivity networks using the amplitude envelope correlation (AEC), weighted phase lag index (wPLI) and directed phase lag index (dPLI). This will be conducted in delta (0.5-4Hz), theta (4-7 Hz), alpha (8-13 Hz) and beta (14-30 Hz) frequency bands for all pairwise combinations of electrode channels on 10-sec windows. From wPLI and AEC matrices, investigators will calculate: * Global functional connectivity * Binary smallworldness * Clustering coefficient * Modularity * Characteristic Path Length * Global Efficiency * Hub posteriority ratio dPLI will be used to assess feedback dominance index. Investigators will also calculate : * Lempel-Ziv complexity * Edge-of-chaos criticality * Pair correlation function * Order parameter

    5 minutes

  • Stimulation

    EEG recording will take place during the 30 seconds of tetanic stimulation, with a 128-channel EEG saline net (measured in microvolts - mV). Investigators will construct functional connectivity networks using the amplitude envelope correlation (AEC), weighted phase lag index (wPLI) and directed phase lag index (dPLI). This will be conducted in delta (0.5-4Hz), theta (4-7 Hz), alpha (8-13 Hz) and beta (14-30 Hz) frequency bands for all pairwise combinations of electrode channels on 10-sec windows. From wPLI and AEC matrices, investigators will calculate: * Global functional connectivity * Binary smallworldness * Clustering coefficient * Modularity * Characteristic Path Length * Global Efficiency * Hub posteriority ratio dPLI will be used to assess feedback dominance index. Investigators will also calculate: * Lempel-Ziv complexity * Edge-of-chaos criticality * Proximity to criticality * Pair correlation function * Order parameter

    30 seconds

  • Post-Stimulation

    EEG recording will continue 5 minutes after tetanic stimulation, with a 128-channel EEG saline net (measured in microvolts - mV). Investigators will construct functional connectivity networks using amplitude envelope correlation (AEC), weighted phase lag index (wPLI) and directed phase lag index (dPLI). This will be conducted in delta (0.5-4Hz), theta (4-7 Hz), alpha (8-13 Hz) and beta (14-30 Hz) frequency bands for all pairwise combinations of electrode channels on 10-sec windows. From wPLI and AEC matrices, investigators will calculate: * Global functional connectivity * Binary smallworldness * Clustering coefficient * Modularity * Characteristic Path Length * Global Efficiency * Hub posteriority ratio dPLI will be used to assess feedback dominance index To assess complexity and criticality, investigators will also calculate: * Lempel-Ziv complexity * Edge-of-chaos criticality * Proximity to criticality * Pair correlation function * Order parameter

    5 minutes

Secondary Outcomes (16)

  • Baseline value of the nocicpetion level index (NOL) - Awake

    1 minute

  • Baseline value of the bispectral index (BIS) - Awake

    1 minute

  • Baseline value of the mean arterial pressure (MAP) - Awake

    1 minute

  • Baseline value of the heart rate (HR) - Awake

    1 minute

  • Basal value of the nocicpetion level index (NOL) - Pre-stimulation

    1 minute

  • +11 more secondary outcomes

Study Arms (1)

Participants

Potential participants for the study will be approached by phone on the day prior to their surgery. Details of the study will be explained to the potential participant by a member of the study team, who will also verify inclusion/exclusion criteria. The morning of the surgery, co-investigators will meet the patients to address any concerns. Written informed consent will be obtained by a member of the study team who is not a member of the patient's treating team. Participants will then receive the interventions described in the ''Interventions'' section.

Other: EEG-hd (high density electroencephalogram)

Interventions

EEG-hd (high density electroencephalogram)OTHER

Once in the operating room, the investigators will place a 128-channel Hd-EEG (high density electroencephalogram) saline net referenced to Cz on the patient's head. Impedances will be verified and maintained \<50 kΩ for the duration of the study. The patient will be positioned supine and all routine monitors will be installed. A 5 minutes baseline resting-state Hd-EEG with eyes closed will be performed before induction. Once under general anesthesia and intubated, a "no pain period" of 5 minutes will take place. During this 5-min period, resting-state Hd-EEG recording will be recorded. A standardized tetanic stimulation to the ulnar nerve of the non-dominant forearm delivered by a routine nerve stimulator (100 Hz, 70 mA) for a duration of 30 seconds will then be applied. Hd-EEG recording will take place during this 30 seconds and will continue during the 5 minutes after. Once this period will be over, the Hd-EEG net will be removed and the investigators will exit the operating room.

Participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for surgery under general anesthesia

You may qualify if:

  • years old
  • French or English language comprehension
  • ASA score I or II (American Society of Anesthesiologists (ASA) Physical Status Classification System)

You may not qualify if:

  • Unstable coronary pathology
  • Heart rhythm disorder
  • Emergency surgery
  • Pregnancy
  • Preoperative hemodynamic failure
  • Drug or alcohol dependence in the last 6 months
  • Chronic psychotropic drug use for more than 3 months
  • Opioid use in the last 6 weeks or chronic pain conditions
  • Psychiatric pathologies
  • Allergy to one of the study products
  • Difficult intubation
  • Unexpected preoperative complication
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Duclos, Ph.D

    Ciusss de L'Est de l'Île de Montréal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Duclos, Ph.D

CONTACT

514-338-2222catherine.duclos@umontreal.ca

Naomie Lussier, B.Sc

CONTACT

819-437-7934naomie.lussier@umontreal.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regular Researcher and Assistant Professor-Researcher, Department of anesthesiology and pain medicine

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 30, 2023

Study Start

June 12, 2023

Primary Completion

November 22, 2023

Study Completion

May 22, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

CA(1)