Change in Brain Perfusion During Induction of General Anesthesia

NCT04288869 | Unknown

• 2 other identifiers: APHP1909452019-A02516-51
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral perfusion; general anesthesia; hypotension; transcranial Doppler; Bispectral Index; Near-infrared spectroscopy

Outcome Measures

Primary Outcomes (4)

• Mean arterial blood pressure

  For all patients, the mean arterial pressure (unit mmHg) will be collected continuously, 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

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

• Cerebral blood flow velocity

  For all patients, CFV (unit cm/s) will be collected continuously, using Transcranial Doppler, 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.

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

• Burst Suppression

  Continuous measurement of burst suppression (BS; %) with use of Bispectral Index (BIS) 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.

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

• Cerebral oxygen saturation

  For all patients, the cerebral oxygen saturation (SO2; %) will be collected continuously, using Near-infrared spectroscopy, 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.

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

Study Arms (1)

Interventional radiology or surgery under general anesthesia

Monitoring of patients (mean arterial blood pressure, Transcranial Doppler , bispectral index, near infrared spectroscopy) who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia during the interventional neuroradiology or orthopedic surgery in adults .

Other: Continuous monitoring of arterial blood pressure; Other: Transcranial Doppler; Other: Bispectral Index (BIS); Other: Near-infrared spectroscopy

Interventions

Continuous monitoring of arterial blood pressure OTHER

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.

Interventional radiology or surgery under general anesthesia

Transcranial Doppler OTHER

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.

Interventional radiology or surgery under general anesthesia

Bispectral Index (BIS) OTHER

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

Interventional radiology or surgery under general anesthesia

Near-infrared spectroscopy OTHER

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.

Interventional radiology or surgery under general anesthesia

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

The study involves major patients who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anesthesia during an interventional neuroradiology procedure or orthopedic surgery.

You may qualify if:

• Major patients (≥ 18 years old)
• Eligible for an interventional radiology procedure or orthopedic surgery under general anesthesia.
• Patients who expressed their non-opposition to participation in this research

You may not qualify if:

• Patients under the age of 18.
• Patient opposed to participation in the protocol
• Pregnant woman
• Patient under judicial protection measure
• Patient without affiliation to a social security scheme-

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• LMS Ecole polytechnique: collaborator
• M3DISIM Inria Université Paris-Saclay: collaborator

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Ultrasonography, Doppler, Transcranial; Consciousness Monitors; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Surgical Equipment; Equipment and Supplies; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

+33 (0)1 49 95 83 74; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD

CONTACT

+33 (0)1 49 95 80 71; fabrice.vallee@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: January 27, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

FR (1)