Brain Power Spectral Density Under Propofol

NCT03876379 | Completed

• 1 other identifier: Brain Spectral 2016
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the operating room, the state of anesthesia is monitored during general anesthesia-induced hypnosis through EEG-based neuro-monitoring. Recent studies suggest that variables extracted from per-operative EEG change as brain ages. Furthermore, aging is itself an independant factor associated to an increased sensitivity to General Anesthesia (GA). Among fragility sign, per-operative Burst Suppression (BS) has been associated to a poor postoperative cognitive trajectory. The main goal of this observational clinical study is to extend the traditional use of per-operative EEG to the detection and prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).

Conditions

Radiography; Orthopedic Surgery; Interventional

Keywords

Depth of anesthesia; brain fragility; electrographic suppression; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (4)

• Values of Patient State Index (PSI-) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

  For all patients values of Patient State Index (PSI -) will be collected during Total Anesthesia Period (induction and hypnotic periods)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

• Propofol doses administered with Target Controlled Infusion (TCI in µg/ml)

  For all patients values of Target Controlled Infusion (TCI in µg/ml ) will be collected during Total Anesthesia Period (induction and hypnotic periods)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

• Values of Burst Suppression (in % of time) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

  For all patients values of Burst Suppression (in % of time) will be collected during Total Anesthesia Period (induction and hypnotic periods)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

• Values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8)

  For all patients values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) will be collected during Total Anesthesia Period (induction and hypnotic periods)

  Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]]

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

Patients \> 18 years scheduled an elective interventional neuroradiology procedure or orthopedic surgery performed under general anesthesia

You may qualify if:

• Patients \> 18 years scheduled an elective interventional neuroradiology procedure or orthopedic surgery performed under general anesthesia.
• oral agreement obtained from each patient before anesthesia

You may not qualify if:

• age \<18 years
• an emergency procedure

Sponsors & Collaborators

• Joaquim MATEO: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Joaquim MATEO, MD

  HLariboisiere LeTemple

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: January 24, 2015
• Primary Completion: January 5, 2016
• Study Completion: January 5, 2016
• Last Updated: March 15, 2019

Record last verified: 2019-03