Clinical trial NCT02435875: Perioperative Baroreflex Sensitivity
Official title: The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Hemodynamic Instability
Surgery
Keywords: hypertension
perioperative
baroreflex sensitivity
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing ordinary thoracic surgery

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.

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.

Eligibility 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;

Primary outcomes:
measure: baroreflex sensitivity
timeFrame: during operation
Secondary outcomes:
measure: interoperation complication
timeFrame: during operation
measure: length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: post-operative complications
timeFrame: 3 days postoperation
measure: hospitalization costs
timeFrame: 2 weeks postoperation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
name: WEIFENG YU, MD
role: STUDY_CHAIR
References: