Agitation in Post Operative Neurosurgical Patients

NCT00590499 | Completed

• 1 other identifier: BJTTH-ICU-07-012
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation; Craniotomy

Keywords

agitation; craniotomy; incidence; risk factor; outcome

Outcome Measures

Primary Outcomes (1)

• Complications: self-removal of endotracheal tube, central venous or bladder catheters.

  24 hours

Secondary Outcomes (1)

• ICU stay and Glasgow Outcome Scale

  At hospital discharge

Study Arms (2)

agitation group

The Riker sedation-agitated scale (SAS) levels 5-7.

non-agitation group

The Riker sedation-agitated scale (SAS) levels 1-4.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 25493435 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Jian-Xin Zhou, MD

  ICU, Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

CN (1)