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Multicenter Study Clinical Trial
Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study.
- Li-Mei Yan, Han Chen, Rong-Guo Yu, Zhu-Heng Wang, Guan-Hua Zhou, Yong-Jin Wang, Xia Zhang, Ming Xu, Lu Chen, Jian-Xin Zhou, and Acute Brain Injury and Critical Care Research Collaboration (ABC Research Collaboration).
- Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China Department of Critical Care Medicine, Inner Mongolia People's Hospital, Hohhot, Inner Mongolia, China.
- BMJ Open. 2015 Jan 1;5(4):e007542.
IntroductionEmergence agitation after intracranial surgery is an important clinical issue during anaesthesia recovery. The aim of this multicentre cohort study is to investigate the incidence of emergence agitation, identify the risk factors and determine clinical outcomes in adult patients after intracranial surgery under general anaesthesia. Additionally, we will deliberately clarify the relationship between postoperative pneumocephalus and agitation.Methods And AnalysisThe present study is a prospective multicentre cohort study. Five intensive care units (ICUs) in China will participate in the study. Consecutive adult patients admitted to the ICUs after intracranial surgery will be enrolled. Sedation-Agitation Scale (SAS) or Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the patients 12 h after the enrolment. Agitation is defined as an SAS score of 5-7, or an RASS score of +2 to +4. According to the maximal SAS and RASS score, patients will be divided into two cohorts: the agitation group and the non-agitation group. Factors potentially related to emergence agitation will be collected at study entry, during anaesthesia and operation, during postoperative care. Univariate analyses between the agitation and the non-agitation groups will be performed. The stepwise backward logistic regression will be carried out to identify the independent predictors of agitation. Patients will be followed up for 72 h after the operation. Accidental self-extubation of the endotracheal tube and removal of other catheters will be documented. The use of sedatives and analgesics will be collected.Ethics And DisseminationEthics approval has been obtained from each of five participating hospitals. Study findings will be disseminated through peer-reviewed publications and conference presentations.Trial Registration NumberNCT02318199.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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