Cerebral Perfusion Variation During Blood Pressure Changes Under General Anesthesia

NCT05803876 | Unknown

• 2 other identifiers: APHP2300722022-A02647-36
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The risk associated with arterial hypotension during general anesthesia for surgery has been demonstrated , but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output, and oxygen transport), and the patient's terrain. Currently, a mean arterial pressure greater than 60 mm Hg and a reduction of less than 30-50% from the value measured before general anesthesia are commonly used treatment thresholds to ensure good perfusion of all organs. Normally, cerebral blood flow is auto-regulated, which allows cerebral blood flow to adapt to oxygen requirements and to different levels of blood pressure, both high and low. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient. The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with and without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during general anesthesia. What is the target level of blood pressure tolerable for a patient under general anesthesia? Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially its adequacy to the brain's oxygen needs?

Conditions

General Anesthesia

Keywords

Cerebrovascular Autoregulation; neurovascular coupling; Individualized vs Standard Blood Pressure Management Strategies; Multimodal monitoring; Brain Oxygen Saturation

Outcome Measures

Primary Outcomes (5)

• mean arterial pressure

  Continuous non-invasive measurement of mean arterial pressure (MAP, mmHg)

  1 day

• cerebral blood velocity in the middle cerebral artery

  Measurement of cerebral blood velocity in the middle cerebral artery by Transcranial Pulsed Doppler. This corresponds to the Mean velocity (Vm) expressed in cm/s.

  1 day

• burst suppression

  Continuous measurement of burst suppression (BS) (%)

  1 day

• 95% spectral frequency front

  Continuous measurement of a 95% spectral frequency front (SEF95) on the frontal EEG

  1 day

• delivered doses of hypnotics, morphine and paralytic agents

  Quantification of delivered doses of hypnotics, morphine and paralytic agents

  1 day

Secondary Outcomes (1)

• Cerebral O2 saturation

  1 day

Study Arms (1)

General anesthesia

Patients undergoing surgery under general anesthesia with an intravenous anesthesia protocol with a concentration target (Orchestra® Base Primea - Fresenius Kabi France), a vasopressor support by norepinephrine and blood pressure optimisation.

Other: Diagnostic test - monitoring

Interventions

Diagnostic test - monitoring OTHER

Continuous measurement of blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) Atys Medical TCD-X®. The probe attachment system on the patient's head looks like a pair of glasses; it is light and comfortable. The orientation of the robotic probe is automatically readjusted to ensure stable recording quality over time. (recorded on Data Warehouse Connect). For all patients Vm in (cm/s) will be collected during the adjustment of the mean arterial pressure level between 90% and 70% of the baseline value, without ever going below 60 mmHg for the patients at low risk and 80 mmHg for the patients at high cardiovascular risk.

Also known as: Non-invasive measurement of cerebral blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) (Mean velocity, Vm, cm/s)

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

Patients undergoing surgery under general anesthesia with an intravenous anesthesia protocol with a concentration target (Orchestra® Base Primea - Fresenius Kabi France), a vasopressor support by norepinephrine and blood pressure optimisation.

You may qualify if:

• Patients of legal age (≥ 18 years)
• Eligible for scheduled surgery at Lariboisière Hospital
• Informed patient who has expressed no objection to participating in this research

You may not qualify if:

• Patients under 18 years of age.
• Patient opposed to participation in the protocol
• Pregnant woman
• Patient under judicial protection
• Patient not affiliated to a social health system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Study Sites (1)

Joaquim MATEO

Paris, 75010, France

RECRUITING

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

+33 (0)149958374; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD, PhD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 7, 2023
• Study Start: July 20, 2023
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)