03713nas a2200457 4500000000100000008004100001260001600042653001000058653001100068653001100079653000900090653000900099653001600108653001700124653001500141653001900156653001900175653002200194653001600216653002800232653001200260653004200272653002300314653002800337653001600365100001300381700001600394700001100410700001700421700001800438700001400456700002000470700001700490700001200507700001700519245014400536300000600680490000700686520254800693022001403241 2016 d c9422508911710aAdult10aFemale10aHumans10aAged10aMale10aMiddle Aged10aHypertension10aAdolescent10aCohort Studies10aBlood Pressure10aAged, 80 and over10aYoung Adult10aAntihypertensive Agents10aBeijing10aBlood Pressure Monitoring, Ambulatory10aCervical Vertebrae10aDecompression, Surgical10aSpondylosis1 aLiu Hong1 aWang Hai-Bo1 aWu Lin1 aWang Shi-Jun1 aYang Ze-Chuan1 aMa Run-Yi1 aReilly Kathleen1 aYan Xiao-Yan1 aJi Ping1 aWu Yang-feng00aEffects of decompressive cervical surgery on blood pressure in cervical spondylosis patients with hypertension: a time series cohort study. a20 v163 a
BACKGROUND: 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. Thus, the purpose of this study is to investigate the effect of cervical decompressive surgery on blood pressure among CSM patients with hypertension.
METHODS/DESIGN: The 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 2(nd) and 3(rd), 4(th) 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.
DISCUSSION: This 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 REGISTRATION: The study is registered to Clinical Trials.gov (NCT02016768).
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