Perioperative Baroreflex Sensitivity

April 30, 2015 updated by: DAN HUANG, RenJi Hospital

The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • DAN HUANF, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing ordinary thoracic surgery

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baroreflex sensitivity
Time Frame: during operation
Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interoperation complication
Time Frame: during operation
Assessment of the incident of severe arrhythmia and blood pressure fluctuations
during operation
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
participants will be followed for the duration of hospital stay, an expected average of 5 days
post-operative complications
Time Frame: 3 days postoperation
Assessment of the incident of myocardial infarction,cerebral infarction and renal failure
3 days postoperation
hospitalization costs
Time Frame: 2 weeks postoperation
Hospitalization costs will be assessed after patients discharged from hospital
2 weeks postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Chair: WEIFENG YU, MD, Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renji1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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