NCT03897790

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

Same day

First QC Date

March 27, 2019

Last Update Submit

September 25, 2019

Conditions

Keywords

cerebral vasoreactivitytranscranial dopplerhypertensive diseaseelderlyvasopressorsgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Variation of the velocity of the middle cerebral artery with vasoconstrictors and during a modification of EtCO2.

    Measurements from transcranial doppler velocity of the middle cerebral artery

    48 hours

Secondary Outcomes (1)

  • Variation of cardiac output with vasoconstrictors and during modification of EtCO2.

    48 hours

Study Arms (1)

Patients under vasoconstrictor

Patients older than 65 years old and hypertensive, requiring vasoconstrictor (phenylephrine or Neosynephrine) during general anesthesia.

Other: Transcranial Doppler (DTC)

Interventions

Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler

Patients under vasoconstrictor

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

population, older over 65 years and hypertensive blood pressure disease with general anesthesia in Tours Hospital in France.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Ultrasonography, Doppler, TranscranialDitiocarb

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative TechniquesThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSulfur Compounds

Study Officials

  • Marc LAFFON, MD-PhD

    Univsersity Hospital, Tours

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 1, 2019

Study Start

April 2, 2019

Primary Completion

April 2, 2019

Study Completion

April 2, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09