Cerebral Perfusion During Induction of General Anesthesia

NCT03769142 | Completed

• 1 other identifier: SRLF 11-356
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 using the simultaneously measure of TCD, NIRS and BIS. Those measures will be also repeated during and after treatment of arterial hypotension episodes in both groups.

Conditions

Radiography; Interventional

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Continuous measure of mean arterial pressure in mmHg (MAP)

  For all patients, mean arterial pressure will be collected at three distinct periods: (1) Baseline or during pre-oxygenation at FiO2 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)

• Measure of cerebral blood flow (CFV in cm/s) with Transcranial Doppler

  For all patients, cerebral flow velocity will be collected at three distinct periods: (1) Baseline or during pre-oxygenation at FiO2 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)

• Continuous measure of Burst Suppression (BS in %) with Bispectral Index (BIS)

  For all patients, Burst Supression will be collected at three distinct periods: (1) Baseline or during pre-oxygenation at FiO2 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)

• Continuous measure of cerebral oxygen saturation (SO2 in %) with Near-infrared spectroscopy (NIRS)

  For all patients, cerebral oxygen saturation will be collected at three distinct periods: (1) Baseline or during pre-oxygenation at FiO2 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)

Interventions

All monitoring PROCEDURE

All monitoring (TCD, BIS, NIRS) are collected from the healthy side, contralateral to the interventional side

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 with scheduled an elective interventional neuroradiology procedure requiring general anesthesia

You may qualify if:

• patients \> 18 years, scheduled an elective interventional neuroradiology procedure requiring general anesthesia
• oral agreement obtained from each patient before anesthesia

You may not qualify if:

• age \<18 years
• an emergency procedure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• Department of Anesthesiology, Hopital Foch, Suresnes, France.: collaborator
• M3DISIM: collaborator
• Ouctomes Research Consortium, Cleveland Clinic, Ohio, USA: collaborator

Related Publications (1)

• Manquat E, Ravaux H, Kindermans M, Joachim J, Serrano J, Touchard C, Mateo J, Mebazaa A, Gayat E, Vallee F, Cartailler J. Impact of impaired cerebral blood flow autoregulation on electroencephalogram signals in adults undergoing propofol anaesthesia: a pilot study. BJA Open. 2022 Mar 2;1:100004. doi: 10.1016/j.bjao.2022.100004. eCollection 2022 Mar.

  PMID: 37588691 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: December 7, 2018
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 7, 2018

Record last verified: 2018-10