Asia Pacific Journal of Clinical Trials: Nervous System Diseases

STUDY PROTOCOL
Year
: 2016  |  Volume : 1  |  Issue : 1  |  Page : 6--11

Postoperative sedation by intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage: study protocol for a randomized parallel-cohort controlled trial


Chao-liang Tang, Jun Li 
 Department of Anesthesiology, Southern District of Anhui Provincial Hospital, Hefei, Anhui Province, China

Correspondence Address:
Chao-liang Tang
Department of Anesthesiology, Southern District of Anhui Provincial Hospital, Hefei, Anhui Province
China

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«SQ»-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. Ethical issues: The trial was approved by Clinical Research Ethics Committee of Anhui Provincial Hospital, China (permission No. 2015 ethics No. 07).


How to cite this article:
Tang Cl, Li J. Postoperative sedation by intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage: study protocol for a randomized parallel-cohort controlled trial.Asia Pac J Clin Trials Nerv Syst Dis 2016;1:6-11


How to cite this URL:
Tang Cl, Li J. Postoperative sedation by intranasal dexmedetomidine in patients with hypertensive cerebral hemorrhage: study protocol for a randomized parallel-cohort controlled trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2016 [cited 2021 Jan 27 ];1:6-11
Available from: https://www.actnjournal.com/article.asp?issn=2542-3932;year=2016;volume=1;issue=1;spage=6;epage=11;aulast=Tang;type=0