Hypertensive DiseaseDiVADHNCT03897790
Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients
An observational study of Hypertensive Disease and Elderly, run by University Hospital, Tours.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertensive Disease, Elderly, Vasopressors
- What is being tested?
- Transcranial Doppler (DTC)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2019to 2 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: population, older over 65 years and hypertensive blood pressure disease with general anesthesia in Tours Hospital in France.
Who may be able to join
- older over 65 years
- high blood pressure disease
- need general anesthesia
- need vasopressors : norepinephrine or phenylephrine
- temporal window of transcranial doppler is viable
Who cannot join
- 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
Show all 9Show fewer
- Insulin-dependent diabetes for more than 10 years
- Person under judicial protection
- Opposition to data processing
About this study
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.
Read the 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.
- Conditions
- Hypertensive Disease, Elderly, Vasopressors, General Anesthesia
- Being tested
- Transcranial Doppler (DTC)
- Keywords
- cerebral vasoreactivity, transcranial doppler, hypertensive disease, elderly, vasopressors, general anesthesia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler (DTC)Other
Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler
| Study group | Role | What they receive |
|---|---|---|
| Patients under vasoconstrictor | Patients older than 65 years old and hypertensive, requiring vasoconstrictor (phenylephrine or Neosynephrine) during general anesthesia. Receives: Other: Transcranial Doppler (DTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (1)
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start2 Apr 2019
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Why it stopped: CPP requalification
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc LAFFON, MD-PhD, Study director, Univsersity Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897790
- Sponsor's protocol ID
- RIPH3-RNI19-DiVADH
- Other IDs
- 2019-A00719-48
- Acronym
- DiVADH
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transcranial Doppler Vasoconstrictor Vasoreactivity During General Anesthesia in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03897790
- Acronym / sponsor ID
- DiVADH / RIPH3-RNI19-DiVADH
- Conditions
- Hypertensive Disease, Elderly, Vasopressors, General Anesthesia
- Keywords
- cerebral vasoreactivity, transcranial doppler, hypertensive disease, elderly, vasopressors, general anesthesia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: CPP requalification
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under vasoconstrictor | – | Other: Transcranial Doppler (DTC)Patients older than 65 years old and hypertensive, requiring vasoconstrictor (phenylephrine or Neosynephrine) during general anesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- population, older over 65 years and hypertensive blood pressure disease with general anesthesia in Tours Hospital in France.
Key inclusion criteria (5 listed)
- older over 65 years
- high blood pressure disease
- need general anesthesia
- need vasopressors : norepinephrine or phenylephrine
- temporal window of transcranial doppler is viable
Key exclusion criteria (9 listed)
- Acute, valvular, rhythmic or ischemic cardiovascular pathology
- severe arthritis (stage 3)
- Intra-cranial pathology
- Significant carotid stenosis (> 40%) or carotid endarterectomy
- Cervical surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler (DTC)Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler | Other | Patients under vasoconstrictor |
Primary outcome
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
1 secondary outcome
Variation of cardiac output with vasoconstrictors and during modification of EtCO2.
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
Related trials for Hypertensive Disease
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc LAFFON, MD-PhD study director
Univsersity Hospital, Tours
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disease and Elderly, run by University Hospital, Tours.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the velocity of the middle cerebral artery with vasoconstrictors and during a modification of EtCO2. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.