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

Elderly Clinical Trial

— DiVADH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03897790
• Other study ID #: RIPH3-RNI19-DiVADH
• Secondary ID: 2019-A00719-48
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Elderly
• General Anesthesia
• Hypertension
• Hypertensive Disease
• Vasopressors

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