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Perioperative Baroreflex Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435875
Recruitment Status : Unknown
Verified April 2015 by DAN HUANG, RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
DAN HUANG, RenJi Hospital

Brief Summary:
Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play an important role in the long-term development of hypertension. Perioperative patients with hypertension is rapidly growing in all populations worldwide. However, no study has reported the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for hypertension in a surgery cohort.

Condition or disease Intervention/treatment
Hypertension Hemodynamic Instability Surgery Other: no intervention

Detailed Description:

Hypertension is known to be a major risk factor of end-organ damage, stroke and coronary mortality.It is estimated that one in six people worldwide, or nearly one billion, are affected by high blood pressure, and it is estimated that this number will increase to 1.5 billion by 2025. The World Health Organization also stated that high blood pressure is the most attributable cause of cardiovascular death.As the speed of aging is accelerated, the amount of perioperative hypertensive patients continue to increase. Perioperative hypertension had been shown to be a risk factor for the development of perioperative morbidity and mortality.Although it has aroused people's attention, there still lack of system evaluation and effective control. Therefore, it's urgent and necessary to assess and intervene perioperative situation of hypertensive patients.

The pathogenesis of hypertension is very complex, while the exact mechanism is still unclear. The dysfunction of autonomic activity, marked in particular by sympathetic overactivity and reduced parasympathetic activity, has been hypothesized to underlie the development of hypertension.Baroreflex control is one of the key mechanisms responsible for the short-term control of blood pressure.It acts as a closed loop, negative feedback mechanism, aimed at stabilizing blood pressure around a set point value.The impairment of baroreflex sensitivity (BRS) is know as the predictive factor of mortality in hypertension. A large of clinical and basic research indicated the existence of autonomic dysfunction and impaired BRS in patients with essential hypertension.

However, no study has reported the values of perioperative BRS, especially in hypertensive patients . Therefore, the aim of this study was to estimate the value of BRS for hypertension in a surgery cohort, and to explore the functional status of autonomic nervous system, may provide reference for clinical treatment.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
hypertensive
Patients with confirmed hypertension or systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg without antihypertensive treatment.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin.
Other: no intervention
Antihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic

nonhypertensive
systolic blood pressure <140 mmHg and diastolic blood pressure<90 mmHg.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin.
Other: no intervention
Antihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic




Primary Outcome Measures :
  1. baroreflex sensitivity [ Time Frame: during operation ]
    Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation


Secondary Outcome Measures :
  1. interoperation complication [ Time Frame: during operation ]
    Assessment of the incident of severe arrhythmia and blood pressure fluctuations

  2. length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    This assess how long patients stay in hospital

  3. post-operative complications [ Time Frame: 3 days postoperation ]
    Assessment of the incident of myocardial infarction,cerebral infarction and renal failure

  4. hospitalization costs [ Time Frame: 2 weeks postoperation ]
    Hospitalization costs will be assessed after patients discharged from hospital



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing ordinary thoracic surgery
Criteria

Inclusion Criteria:

  1. Patients undergoing ordinary thoracic surgery and age between 18 and 70;
  2. American society of anesthesiologists(ASA) classification I to II level;
  3. Willing to participate in this study and signed an informed consent

Exclusion Criteria:

1.Patients with diabetes mellitus, cardiopulmonary dysfunction, severe liver and kidney dysfunction and disease of nervous system;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435875


Contacts
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Contact: DAN HUANG, MS 15921108822 huangdan363@163.com
Contact: JIE CHE, MS 13611906592 13611906592@163.com

Locations
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China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: DAN HUANG, MS    15921108822    huangdan363@163.com   
Contact: JIE CHEN, MS    13611906592    13611906592@163.com   
Principal Investigator: DAN HUANF, MS         
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: WEIFENG YU, MD Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
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Responsible Party: DAN HUANG, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT02435875    
Other Study ID Numbers: Renji1501
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: April 2015
Keywords provided by DAN HUANG, RenJi Hospital:
hypertension
perioperative
baroreflex sensitivity
Additional relevant MeSH terms:
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Hypertension
Hypersensitivity
Vascular Diseases
Cardiovascular Diseases
Immune System Diseases