Bispectral index-guided fast track anesthesia by sevoflurane infusion combined with dexmedetomidine for intracranial aneurysm embolization: study protocol for a multi-center parallel randomized controlled trial

Abstract

Background: After intracranial aneurysm embolization, rapid recovery from general anesthesia is necessary for timely monitoring of adverse events. Fast-track anesthesia using a balanced technique or combination of drugs at their minimum required dosages is preferred for these neurosurgical patients. However, fast-track anesthesia is still limited by a lack of standardization and quality control standards. Methods/Design: A multi-center, parallel, randomized controlled clinical trial will be conducted at Anhui Provincial Hospital and Renmin Hospital of Wuhan University, China. One hundred and twenty patients with intracranial aneurysm will be randomly assigned to a normal saline group and a dexmedetomidine group. General anesthesia will be induced intravenously with propofol. Additionally, either 1.0 μg/kg dexmedetomidine or normal saline will be delivered completely within 10 minutes before anesthesia induction. Once anesthesia has begun, dexmedetomidine (0.3 μg/kg per hour) or normal saline will be continuously infused. Intraoperatively, anesthesia will be maintained with 2-3% sevoflurane. Primary outcomes will be anesthesia time, operative time, time from the end of anesthesia until recovering spontaneous breathing, time until eye opening on command, and time until orientation to time and place. Secondary outcomes will be dose of sevoflurane, Visual Analogue Scale score, and bispectral index. Discussion: In this trial, we will assess the clinical efficacy of sevoflurane anesthesia with dexmedetomidine as a fast track anesthesia for intracranial aneurysm embolization. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-IPR-16008113) on 17 March 2016. Ethics: Written approval for this trial has been obtained from the Ethics Committee of the Anhui Provincial Hospital of China (approval No. 2015-31). This study will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Prior to the trial, participants and their family members will be informed of the risks and benefits of this trial. Written informed consent will be obtained from each participant.