Effects of dexmedetomidine combined with sodium creatine phosphate on inflammation, oxidative stress, and neurological function recovery in patients undergoing intracranial hematoma evacuation: study protocol for a multi-center, prospective randomized parallel-cohort controlled trial

Abstract

Background: In treating intracranial hematoma, dexmedetomidine (Dex) exhibits neuroprotective effects by preventing cognitive decline, and sodium creatine phosphate (SCP) exhibits neuroprotective effects by reducing cell death, maintaining the blood-brain barrier and improving interstitial cerebral edema. Few studies have examined the effects of Dex combined with SCP on perioperative inflammation and oxidative stress response, or recovery of neurological function. Methods/Design: Here we propose a multi-center, prospective randomized parallel-cohort controlled trial, to be performed at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. After screening against inclusion and exclusion criteria, 80 patients scheduled to receive intracranial hematoma evacuation will be randomly divided into control, Dex, SCP, and Dex + SCP groups, with 20 patients per group. Under general anesthesia, all patients will undergo craniotomy for hematoma removal. In the Dex and Dex + SCP groups, an intravenous bolus of Dex (0.6 μg/kg) will be administered 10 minutes before anesthesia induction and thereafter intravenous administration of Dex (0.4 μg/kg/h) will be given. In the SCP, and Dex + SCP groups, 1.0 g SCP will be administered 10 minutes before anesthesia induction. The primary outcome measure is the difference in postoperative 72-hour Glasgow Coma Scale (GCS) score and postoperative 12-hour GCS score. The secondary outcome measures include differences in postoperative 48-hour and 24-hour GCS scores and postoperative 12-hour GCS score; plasma levels of inflammatory and oxidative stress markers, and pathological changes in brain tissue before anesthesia induction and at the end of surgery; and physiological indices during surgery. Discussion: We evaluate whether results from the proposed study protocol will provide evidence that the use of Dex combined with SCP in patients undergoing intracranial hematoma evacuation is feasible. Trial registration: The study protocol was registered at Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) on 11 December 2014 (registration number: ChiCTR-IPR-14005656). Ethics: The study protocol was approved by Ethics Committee, Anhui Provincial Hospital, China on 25 November 2014 (approval No. 2014-ethics-39) and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from patient's guardians or clients prior to enrollment in the clinical trial.