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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.