Change in Brain Perfusion During Induction of General Anesthesia

NCT04288869 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2023-10-25

No results posted yet for this study

Summary

Arterial hypotension during general anesthesia remains a factor of poor outcomes, increases the risk of myocardial infarction, acute kidney injury and 1-year mortality. Furthermore, arterial hypotension may also decrease cerebral perfusion contributing to worsen neurological outcome. It seems necessary to monitor cerebral perfusion during anesthesia and to define individual dynamic targets of blood pressure. The goal of this study is to evaluate cerebral perfusion change in adult patients with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared by simultaneous measurements of cerebral blood flow, cerebral oxygen saturation and neurological function with use of transcranial Doppler (TCD), Near infrared spectroscopy (NIRS) and the Bispectral index (BIS) monitoring, respectively. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.

Conditions

  • Interventional Radiology
  • Orthopedic Surgery

Interventions

OTHER

Continuous monitoring of arterial blood pressure

For all patients, mean arterial pressure (unit mmHg) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

OTHER

Transcranial Doppler

Measurement of cerebral blood flow velocity (CFV) with use of Transcranial Doppler ultrasonography. For all patients, CFV (unit cm/s) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

OTHER

Bispectral Index (BIS)

Continuous measurement of burst suppression (BS; %) with use of Bispectral Index (BIS). For all patients, BS will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation

OTHER

Near-infrared spectroscopy

Continuous measurement of cerebral oxygen saturation (SO2) with Near-infrared spectroscopy (NIRS). For all patients, SO2 (%) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

Sponsors & Collaborators

  • INSERM UMR-942, Paris, France

    collaborator OTHER
  • LMS Ecole polytechnique

    collaborator UNKNOWN
  • M3DISIM Inria Université Paris-Saclay

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Joaquim MATEO, MD · Assistance Publique - Hôpitaux de Paris

  • Fabrice VALLEE, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288869 on ClinicalTrials.gov