Clinical trial NCT03897790: Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients
Official title: Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertensive Disease
Elderly
Vasopressors
General Anesthesia
Keywords: cerebral vasoreactivity
transcranial doppler
hypertensive disease
elderly
vasopressors
general anesthesia
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Variation of the velocity of the middle cerebral artery with vasoconstrictors and during a modification of EtCO2.
timeFrame: 48 hours
Secondary outcomes:
measure: Variation of cardiac output with vasoconstrictors and during modification of EtCO2.
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Univsersity Hospital, Tours
name: Marc LAFFON, MD-PhD
role: STUDY_DIRECTOR
References: