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Background: Cerebral hemorrhage is often complicated by conscious disturbance and restlessness regardless of the size or location of the hemorrhage, and sedation is often necessary. Dexmedetomidine has dose-dependent sedative, anxiolytic and analgesic effects. It is suited to patients undergoing mechanical ventilation for traumatic brain injury; however, its sedative effects cannot easily be controlled in patients breathing spontaneously. We will investigate the safety and efficacy of postoperative intranasal dexmedetomidine in patients undergoing craniotomy for hypertensive cerebral hemorrhage. Methods/Design: A randomized parallel-cohort controlled trial will be performed at the South District of Anhui Provincial Hospital, China. Patients with hypertensive cerebral hemorrhage will be randomly divided into groups treated with 0.9% normal saline (placebo), or dexmedetomidine 1 or 1.5 μg/kg. Study drug, either undiluted dexmedetomidine 1 or 1.5 μg/kg (dexmedetomidine group) or equal volume of 0.9% normal saline (placebo group), will be administered immediately to each naris as drops after craniotomy for evacuation of hematoma. Primary outcomes include systolic blood pressure, diastolic blood pressure, heart rate, peripheral oxygen saturation, intracranial pressure, Glasgow Coma Scale score, the level of inflammatory markers in the cerebrospinal fluid, and the levels of malondialdehyde, superoxide dismutase, 4-hydroxynonenal, neurotensin, 8-hydroxy-2'-deoxyguanosine and corticosteroid in serum. Secondary outcomes are volume of hematoma, body weight, duration of surgery, duration of anesthesia, blood loss, urine output and length of hospital stay. Discussion: The results of this trial will provide evidence for the safe and effective postoperative use of intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage who are not mechanically ventilated. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) identifier: ChiCTR-IPR-15006668; registered on 30 June 2015.

背景：无论脑出血的体积与部位如何，高血压性脑出血患者常并发意识障碍与躁动，镇静治疗往往不可或缺。右美托咪定（dexmedetomidine）具有剂量依赖性的镇静、抗焦虑与镇痛作用，适用于颅脑创伤行机械通气的患者；但对于自主呼吸患者，其镇静效果较难调控。本研究拟探讨术后经鼻给予右美托咪定在高血压性脑出血开颅手术患者中的安全性与有效性。方法与设计：本研究为随机平行队列对照试验，将在中国安徽省立医院南区开展。高血压性脑出血患者将被随机分为三组：0.9%生理盐水（安慰剂）组、右美托咪定1μg/kg组与右美托咪定1.5μg/kg组。研究药物（未稀释的右美托咪定1μg/kg或1.5μg/kg，或等体积的0.9%生理盐水）将在开颅血肿清除术后即刻经鼻滴入双侧鼻孔。主要结局指标包括收缩压、舒张压、心率、外周血氧饱和度、颅内压、格拉斯哥昏迷量表（Glasgow Coma Scale）评分、脑脊液炎症标志物水平，以及血清中丙二醛、超氧化物歧化酶、4-羟基壬烯醛、神经降压素、8-羟基-2'-脱氧鸟苷与皮质类固醇水平。次要结局指标包括血肿体积、体质量、手术时长、麻醉时长、失血量、尿量与住院时长。讨论：本试验结果将为未行机械通气的高血压性脑出血患者术后经鼻给予右美托咪定的安全有效应用提供循证依据。试验注册：中国临床试验注册中心（http://www.chictr.org.cn/index.aspx），注册号：ChiCTR-IPR-15006668，注册日期：2015年6月30日。