Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Perfusion During Induction of General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769142
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
INSERM UMR-942, Paris, France
Department of Anesthesiology, Hopital Foch, Suresnes, France.
M3DISIM
Ouctomes Research Consortium, Cleveland Clinic, Ohio, USA
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Radiography Interventional Procedure: All monitoring

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cerebral Perfusion Changes During General Anesthesia Induction: Relation Between Transcranial Doppler, Bispectral Index and Cerebral Oximetry: a Prospective Observational Study
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Intervention Details:
  • Procedure: All monitoring
    All monitoring (TCD, BIS, NIRS) are collected from the healthy side, contralateral to the interventional side


Primary Outcome Measures :
  1. Continuous measure of mean arterial pressure in mmHg (MAP) [ Time Frame: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day) ]
    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

  2. Measure of cerebral blood flow (CFV in cm/s) with Transcranial Doppler [ Time Frame: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day) ]
    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.

  3. Continuous measure of Burst Suppression (BS in %) with Bispectral Index (BIS) [ Time Frame: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day) ]
    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.

  4. Continuous measure of cerebral oxygen saturation (SO2 in %) with Near-infrared spectroscopy (NIRS) [ Time Frame: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with scheduled an elective interventional neuroradiology procedure requiring general anesthesia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age <18 years
  • an emergency procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769142


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM UMR-942, Paris, France
Department of Anesthesiology, Hopital Foch, Suresnes, France.
M3DISIM
Ouctomes Research Consortium, Cleveland Clinic, Ohio, USA
Investigators
Layout table for investigator information
Principal Investigator: Joaquim MATEO, MD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03769142     History of Changes
Other Study ID Numbers: SRLF 11-356
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
cerebral perfusion
hypotension
transcranial Doppler
general anesthesia
Bispectral Index
Near-infrared spectroscopy (NIRS)

Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs