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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03897790
Other study ID # RIPH3-RNI19-DiVADH
Secondary ID 2019-A00719-48
Status Withdrawn
Phase
First received
Last updated
Start date April 2, 2019
Est. completion date April 2, 2019

Study information

Verified date September 2019
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2, 2019
Est. primary completion date April 2, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

Other:
Transcranial Doppler (DTC)
Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Variation of cardiac output with vasoconstrictors and during modification of EtCO2. 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
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