Clinical trial NCT00590499: Agitation in Post Operative Neurosurgical Patients
Official title: A Prospective Survey of Emergent Agitation Following Craniotomy: Incidence, Risk Factors and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Agitation
Craniotomy
Keywords: agitation
craniotomy
incidence
risk factor
outcome
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 consecutive adult patients admitted to Neuro-ICU for post-operative care following craniotomy

Brief summary: Agitation is a significant clinical issue in anesthesiology and critical care medicine. Several studies have carried out to survey the epidemics of agitation in post-anesthesia care unit and intensive care unit, and results revealed that agitation had an adverse impact on outcomes. To our clinical experience, agitation can occur in postoperative neurosurgical patients, and is often difficult to manage. However, agitation in this subset of patients is poorly evaluated. In present study, adult patients following craniotomy will be enrolled consecutively, and incidence, risk factor and outcome of emergent agitation will be investigated. The results of the study will provide basic data for prevention and treatment of agitation in postoperative neurosurgical patients.

Detailed description: The study will enroll 120 consecutive adult patients admitted to Neuro-ICU for post-operative care following craniotomy. Sedation-Agitation Scale (SAS) will be evaluated and documented every hour or as needed during stay in ICU by nurse on duty. Emergent agitation is defined as SAS of 5 to 7 at anytime during the first 24 hr of ICU stay.Patients are divided into 2 groups: non-agitation group (SAS 1-4) and agitation group (SAS 5-7).Data collection includes pre-operative records, events during anesthesia and operation, events during ICU stay, and outcomes. The primary outcome is complications such as self-removal of endotracheal tube, central venous or bladder catheters. The secondary and third outcomes are ICU stay and Glasgow Outcome Scale at hospital discharge, respectively. Incidence of agitation will be calculated to present an epidemiological knowledge. Univariate analyses between the two groups will be used for preliminary selection of model variables. Then stepwise block logistic regression will be applied to model the risk of agitation using significant univariate predictors.

Eligibility criteria: Inclusion Criteria:

* adult patients admitted to Neuro-ICU for post-operative care following craniotomy

Exclusion Criteria:

* age\<18 yr old
* time interval between operation to ICU admission is longer than 24 hr
* re-operation within 72 hr
* persistently comatose during first 24 hr after operation (GCS≤8)

Primary outcomes:
measure: Complications: self-removal of endotracheal tube, central venous or bladder catheters.
timeFrame: 24 hours
Secondary outcomes:
measure: ICU stay and Glasgow Outcome Scale
timeFrame: At hospital discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jian-Xin Zhou
state: Beijing
Study officials:
affiliation: ICU, Beijing Tiantan Hospital
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
citation: Chen L, Xu M, Li GY, Cai WX, Zhou JX. Incidence, Risk Factors and Consequences of Emergence Agitation in Adult Patients after Elective Craniotomy for Brain Tumor: A Prospective Cohort Study. PLoS One. 2014 Dec 10;9(12):e114239. doi: 10.1371/journal.pone.0114239. eCollection 2014.