Agitation in Post Operative Neurosurgical Patients

Agitation Clinical Trial

Official title:

A Prospective Survey of Emergent Agitation Following Craniotomy: Incidence, Risk Factors and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590499
• Other study ID #: BJTTH-ICU-07-012
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 29, 2014
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Agitation
• Craniotomy
• Psychomotor Agitation

Locations

Country	Name	City	State
China	Jian-Xin Zhou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications: self-removal of endotracheal tube, central venous or bladder catheters.		24 hours	Yes
Secondary	ICU stay and Glasgow Outcome Scale		At hospital discharge	No