Perioperative Baroreflex Sensitivity

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02435875
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2016
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. baroreflex sensitivity [during operation]

    Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation

Secondary Outcome Measures

  1. interoperation complication [during operation]

    Assessment of the incident of severe arrhythmia and blood pressure fluctuations

  2. length of hospital stay [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 [3 days postoperation]

    Assessment of the incident of myocardial infarction,cerebral infarction and renal failure

  4. hospitalization costs [2 weeks postoperation]

    Hospitalization costs will be assessed after patients discharged from hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital, Shanghai Jiao Tong University, School of Medicine Shanghai Shanghai China 200127

Sponsors and Collaborators

  • RenJi Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DAN HUANG, Dr., RenJi Hospital
ClinicalTrials.gov Identifier:
NCT02435875
Other Study ID Numbers:
  • Renji1501
First Posted:
May 6, 2015
Last Update Posted:
May 6, 2015
Last Verified:
Apr 1, 2015
Keywords provided by DAN HUANG, Dr., RenJi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2015