Agitation in Post Operative Neurosurgical Patients
A Prospective Survey of Emergent Agitation Following Craniotomy: Incidence, Risk Factors and Outcomes
Sponsor: Capital Medical University
This observational or N/A phase trial investigates Agitation and Craniotomy and is currently completed. Capital Medical University leads this study, which shows 6 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed
-
Jul 2024 — Sep 2024 [monthly]
Completed
-
Jan 2021 — Jul 2024 [monthly]
Completed
-
Jun 2018 — Jan 2021 [monthly]
Completed
-
Apr 2018 — Jun 2018 [monthly]
Completed
Phase: NA → None
▶ Show 1 earlier version
-
Jan 2017 — Apr 2018 [monthly]
Completed NA
First recorded
Jul 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Capital Medical University
For direct contact, visit the study record on ClinicalTrials.gov .