title: Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study.
abstract: BACKGROUND
  Emergence 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
  The 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.
  
  
  BACKGROUND
  Ethics approval has been obtained from each of five participating hospitals. Study findings will be disseminated through peer-reviewed publications and conference presentations.
  
  
  BACKGROUND
  NCT02318199.
authors.affiliation: 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.
authors.forename: Li-Mei
authors.initials: LM
authors.lastname: Yan
authors.affiliation: Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China Surgical Intensive Care Unit, Fujian Provincial Clinical College, Fujian Medical University, Fuzhou, Fujian, China.
authors.forename: Han
authors.initials: H
authors.lastname: Chen
authors.affiliation: Surgical Intensive Care Unit, Fujian Provincial Clinical College, Fujian Medical University, Fuzhou, Fujian, China.
authors.forename: Rong-Guo
authors.initials: RG
authors.lastname: Yu
authors.affiliation: Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University, Beijing, China.
authors.forename: Zhu-Heng
authors.initials: ZH
authors.lastname: Wang
authors.affiliation: Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University, Beijing, China.
authors.forename: Guan-Hua
authors.initials: GH
authors.lastname: Zhou
authors.affiliation: Department of Critical Care Medicine, Bethune International Peace Hospital, Hebei Medical University, Shijiazhuang, Hebei, China.
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Wang
authors.affiliation: Department of Critical Care Medicine, Bethune International Peace Hospital, Hebei Medical University, Shijiazhuang, Hebei, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Xu
authors.affiliation: Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Lu
authors.initials: L
authors.lastname: Chen
authors.affiliation: Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
authors.forename: Jian-Xin
authors.identifier: http://orcid.org/0000-0002-1559-7554
authors.initials: JX
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000762:Anesthesia Recovery Period; D000768:Anesthesia, General; D001921:Brain / Q000601:surgery*; D016022:Case-Control Studies; D002681:China; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures; D010149:Postoperative Pain / Q000150:complications / Q000175:diagnosis; D011007:Pneumocephalus / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011446:Prospective Studies; D011595:Psychomotor Agitation / Q000453:epidemiology / Q000209:etiology*; D012307:Risk Factors
keywords: NEUROSURGERY