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

September 25, 2019 updated by: University Hospital, Tours
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Marc LAFFON, MD-PhD, Univsersity Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

April 2, 2019

Study Completion (Actual)

April 2, 2019

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH3-RNI19-DiVADH
  • 2019-A00719-48 (Other Identifier: IdRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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