Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study

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Abstract

Introduction

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 and analysis

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.

Ethics and dissemination

Ethics approval has been obtained from each of five participating hospitals. Study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT02318199.

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Most cited references 15

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Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients.

Andy Fraser, Richard R Riker, Jacques J. Picard (1999)

Subjective scales to assess agitation and sedation in adult intensive care unit (ICU) patients have rarely been tested for validity or reliability. We revised and prospectively tested the Sedation-Agitation Scale (SAS) for interrater reliability and compared it with the Ramsay scale and the Harris scale to test construct validity. A convenience sample of ICU patients was simultaneously and independently examined by pairs of trained evaluators by using the revised SAS, Ramsay, and Harris Scales. Multidisciplinary 34-bed ICU in a nonuniversity, academic medical center. Forty-five ICU patients (surgical and medical) were examined a total of 69 times by evaluator pairs. The mean patient age was 63.2 yrs, 36% were female, and 71% were intubated. When classified by using SAS, 45% were anxious or agitated (SAS 5 to 7), 26% were calm (SAS 4), and 29% were sedated (SAS 1 to 3). Interrater correlation was high for SAS (r2 = .83; p < .001) and the weighted kappa score for interrater agreement was 0.92 (p < .001). Of 41 assessments scored as Ramsay 1, 49% scored SAS 6, 41% were SAS 5, 5% were SAS 4, and 2% each were SAS 3 or 7. SAS was highly correlated with the Ramsay (r2 = .83; p < .001) and Harris (r2 = .86; p < .001) scales. SAS is both reliable (high interrater agreement) and valid (high correlation with the Harris and Ramsay scales) in assessing agitation and sedation in adult ICU patients. SAS provides additional information by stratifying agitation into three categories (compared with one for the Ramsay scale) without sacrificing validity or reliability.

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Emergence delirium in adults in the post-anaesthesia care unit.

Elizabeth A Lautner, L. Liu, C Lepousé … (2006)

Emergence delirium in the post-anaesthesia care unit (PACU) is poorly understood. The goal of this prospective study was to determine frequency and risk factors of emergence delirium in adults after general anaesthesia. In this prospective study, 1,359 consecutive patients were included. Contextual risk factors and occurrence of delirium according to the Riker sedation scale were documented. Groups were defined for the analysis according to the occurrence or not of agitation, then after exclusion of patients with preoperative anxiety and neuroleptics, or both, and antidepressants or benzodiazepines treatments. Sixty-four (4.7%) patients developed delirium in the PACU, which can go from thrashing to violent behaviour and removal of tubes and catheters. Preoperative anxiety was not found to be a risk factor. Preoperative medication by benzodiazepines (OR=1.910, 95% CI=1.101-3.315, P=0.021), breast surgery (OR=5.190, 95% CI=1.422-18.947, P=0.013), abdominal surgery (OR=3.206, 95% CI=1.262-8.143, P=0.014), and long duration of surgery increased the risk of delirium (OR=1.005, 95% CI=1.002-1.008, P=0.001), while a previous history of illness and long-term treatment by antidepressants decreased the risk (respectively, OR=0.544, 95% CI=0.315-0.939, P=0.029 and OR=0.245, 95% CI=0.084-0.710, P=0.010). Preoperative benzodiazepines, breast and abdominal surgery and surgery of long duration are risk factors for emergence delirium.

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Postoperative delirium.

Fabio Vannucci, E Whitlock, M Avidan (2011)

Delirium is a common complication during the postoperative period. Because of its significant associations with physical and cognitive morbidity, clinicians should be aware of the evidence-based practices relating to its diagnosis, treatment, and prevention. Here, we review select recent literature pertaining to the epidemiology and impact of postoperative delirium, the perioperative risk factors for its development and/or exacerbation, and the strategies for its management, with additional attention paid to the population of patients in intensive care units.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2015

Publication date (Electronic): 21 April 2015

Volume: 5

Issue: 4

Electronic Location Identifier: e007542

Affiliations

[1 ]Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University , Beijing, China

[2 ]Department of Critical Care Medicine, Inner Mongolia People's Hospital , Hohhot, Inner Mongolia , China

[3 ]Surgical Intensive Care Unit, Fujian Provincial Clinical College, Fujian Medical University , Fuzhou, Fujian , China

[4 ]Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University , Beijing, China

[5 ]Department of Critical Care Medicine, Bethune International Peace Hospital, Hebei Medical University , Shijiazhuang, Hebei, China

[6 ]Interdepartmental Division of Critical Care Medicine, University of Toronto , Toronto, Ontario, Canada

Author notes

[Correspondence to ] Professor Jian-Xin Zhou; zhoujx.cn@ 123456gmail.com

Author information

Guan-Hua Zhou http://orcid.org/0000-0002-1559-7554

Jian-Xin Zhou http://orcid.org/0000-0002-1559-7554

Article

Publisher ID: bmjopen-2014-007542

DOI: 10.1136/bmjopen-2014-007542

PMC ID: 4410113

PubMed ID: 25900467

SO-VID: 1e240e87-31ea-4314-956d-8151c7354de5

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 25 December 2014

Date revision received : 24 March 2015

Date accepted : 27 March 2015

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Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

SICOT-J (Orthopedic surgery and traumatology)

Most cited references 15

Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients.

Emergence delirium in adults in the post-anaesthesia care unit.

Postoperative delirium.

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Author notes

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