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Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients (DiVADH)

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ClinicalTrials.gov Identifier: NCT03897790
Recruitment Status : Withdrawn (CPP requalification)
First Posted : April 1, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Study Description
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Brief Summary:
During a general anesthesia, people over 65 years old and hypertensive, have a modification of the vasoreactivity and their cerebral blood flow under vasoconstrictor such as norepinephrine or phenylephrine. We study the variation of the average velocity of the average cerebral artery under vasoconstrictor and during a modification of End Tidal CO2 (EtCO2) by transcranial Doppler.

Condition or disease Intervention/treatment
Hypertensive Disease Elderly Vasopressors General Anesthesia Other: Transcranial Doppler (DTC)

Detailed Description:

General anesthesia induces a sympathetic block frequently leading to hypotension, especially in elderly and hypertensive patients. Currently, Phenylephrine (PE) and Norepinephrine (NE) are commonly used in clinical practice to address this arterial pressure drop. Their cardiovascular effects are not exactly the same, even though they both increase mean blood pressure.

Maintenance of mean arterial pressure is not the only hemodynamic goal during general anesthesia in the elderly. Cognitive disorders have been demonstrated during post-anesthetic awakening.

Cerebral hemodynamics is assessed by analyzing the speed of blood flow in the middle cerebral artery using transcranial Doppler (DTC). It measures the systolic and diastolic speed as well as the pulsatility index, which are predictive factors for lowering cerebral blood flow.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients
Actual Study Start Date : April 2, 2019
Actual Primary Completion Date : April 2, 2019
Actual Study Completion Date : April 2, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients under vasoconstrictor
Patients older than 65 years old and hypertensive, requiring vasoconstrictor (phenylephrine or Neosynephrine) during general anesthesia.
 Other: Transcranial Doppler (DTC)
Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler


Outcome Measures
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Primary Outcome Measures :
  1. Variation of the velocity of the middle cerebral artery with vasoconstrictors and during a modification of EtCO2. [ Time Frame: 48 hours ]
    Measurements from transcranial doppler velocity of the middle cerebral artery


Secondary Outcome Measures :
  1. Variation of cardiac output with vasoconstrictors and during modification of EtCO2. [ Time Frame: 48 hours ]
    Measurements from non invasive device (ClearSight System) of the cardiac output. The ClearSight system quickly connects to the patient by wrapping an inflatable cuff around the finger. Then the system presents cardiac output clearly and simply on the monitor.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
population, older over 65 years and hypertensive blood pressure disease with general anesthesia in Tours Hospital in France.
Criteria

Inclusion Criteria:

  • older over 65 years
  • high blood pressure disease
  • need general anesthesia
  • need vasopressors : norepinephrine or phenylephrine
  • temporal window of transcranial doppler is viable

Exclusion Criteria:

  • Acute, valvular, rhythmic or ischemic cardiovascular pathology
  • severe arthritis (stage 3)
  • Intra-cranial pathology
  • Significant carotid stenosis (> 40%) or carotid endarterectomy
  • Cervical surgery
  • Taking a premedication that can modify cerebral vasoreactivity
  • Insulin-dependent diabetes for more than 10 years
  • Person under judicial protection
  • Opposition to data processing
Contacts and Locations
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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): NCT03897790


Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Marc LAFFON, MD-PhD Univsersity Hospital, Tours
More Information
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03897790    
Other Study ID Numbers: RIPH3-RNI19-DiVADH
2019-A00719-48 ( Other Identifier: IdRCB )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
cerebral vasoreactivity
transcranial doppler
hypertensive disease
 elderly
vasopressors
general anesthesia
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases