Abstract
BackgroundPatients with cervical spondylosis myelopathy (CSM) and complicated with hypertension are often experiencing a blood pressure decrease after taking cervical decompressive surgery in clinical observations, but how this blood pressure reduction is associated with the surgery, which cut cervical sympathetic nervous, has never been rigorously assessed. Thus, the purpose of this study is to investigate the effect of cervical decompressive surgery on blood pressure among CSM patients with hypertension.Methods/DesignThe study will be a time series cohort study. Fifty eligible patients will be selected consecutively from the Peking University First Hospital. Two 24-h ambulatory blood pressure measurement (ABPM) will be taken before the surgery, apart by at least 3 days. The patients will be followed up for another two ABPMs at 1 and 3 months after the surgery.We will recruit subjects with cervical spondylosis myelopathy meeting operation indications and scheduled for receiving cervical decompressive surgery, aged 18–84 years, have a history of hypertension or office systolic blood pressure ≥140 mmHg on initial screening, and willing to participate in the study and provide informed consent. Exclusion criteria includes a history of known secondary hypertension, visual analogue scale (VAS) score ≥4, and unable to comply with study due to severe psychosis.The change in systolic ABPs over the four times will be analyzed to observe the overall pattern of the blood pressure change in relation to the surgery, but the primary analysis will be the comparison of systolic ABP between the 2nd and 3rd , 4th measurements (before and after the surgery). We will also calculate the regression-to-the-mean adjusted changes in systolic ABP as sensitivity analysis. Secondary endpoints are the changes in 24 h ABPM diastolic blood pressure, blood pressure control status, the use and dose adjustment of antihypertensive medication, and the incidence of operative complications. Primary outcome analyses will be carried out using analysis of covariance, as well as the first secondary endpoint.DiscussionThis study will inform us the important knowledge about cervical sympathetic nervous system (SNS) and blood pressure. Once confirmed, it may help to produce new method for control of hypertension, which is the leading cause of death in the world.Trial registrationThe study is registered to Clinical Trials.gov (NCT02016768).
Highlights
Patients with cervical spondylosis myelopathy (CSM) and complicated with hypertension are often experiencing a blood pressure decrease after taking cervical decompressive surgery in clinical observations, but how this blood pressure reduction is associated with the surgery, which cut cervical sympathetic nervous, has never been rigorously assessed
The purpose of this study is to investigate the effect of cervical decompressive surgery on resistant hypertension based on a novel mechanistic hypothesis of essential hypertension
In the past several years, a new procedure named renal denervation had been shown to be safe and effective in controlling hypertension, supporting that the sympathetic nervous system (SNS) activity is critical in regulating blood pressure [6, 7]
Summary
Patients with cervical spondylosis myelopathy (CSM) and complicated with hypertension are often experiencing a blood pressure decrease after taking cervical decompressive surgery in clinical observations, but how this blood pressure reduction is associated with the surgery, which cut cervical sympathetic nervous, has never been rigorously assessed. The purpose of this study is to investigate the effect of cervical decompressive surgery on blood pressure among CSM patients with hypertension. Incidence and prevalence of hypertension are increasing, especially in developing countries. The effects of current pharmacologic treatment of hypertension remain suboptimal in both developing and developed countries [3, 4]. The common causes responsible for the poor control of high blood pressure are attributed to physicians’ attitudes and patient non-compliance to lifelong pharmacological therapy for asymptomatic hypertension [5,6,7]. Clinical evidence indicates that the risk of major cardiovascular events is higher among patients with resistant hypertension than that among patients with controlled blood pressure [5]. Developing novel approaches for management of hypertension, especially for resistant hypertension, is an important issue for the future of the treatment of hypertension
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