Emergence Agitation in Adult Patients After Intracranial Surgery

Completed

• Conditions: Neurosurgery; Intensive Care, Surgical; Postoperative Care
• Interventions: Procedure: Anesthesia recovery after intracranial surgery

• Registration Number: NCT02318199
• Lead Sponsor: Capital Medical University

Brief Summary

Emergence agitation is a frequent complication that can have serious consequences during recovery from general anesthesia. However, agitation has been poorly investigated in patients after craniotomy. In this prospective multicenter cohort study, adult patients will be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk factors and outcome will be investigated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Study Start: 2015-01
• Primary Completion: 2015-06
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Both supratentorial and infratentorial intradural cranial operations

Exclusion Criteria

• Unarousable state (SAS=1) during the first 24 hours after the operation
• Interval longer than 24 hours between the end of the surgery and neurosurgical ICU admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Agitation group	Anesthesia recovery after intracranial surgery	Patient is evaluated by the sedation-agitation scale (SAS) during the anesthesia recovery after intracranial surgery under general anesthesia. SAS equals to 5-7 during the first 12 hours after surgery.
Non-agitation group	Anesthesia recovery after intracranial surgery	Patient is evaluated by the sedation-agitation scale (SAS) during the anesthesia recovery after intracranial surgery under general anesthesia. SAS equals to 1-4 during the first 12 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Emergence agitation	12 hours after operation	Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7.

Trial Locations

Locations (4)

Daxing Teaching Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Bethune International Peace Hospital, Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Fujian Provincial Clinical College, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Inner Mongolia People's Hospital; 🇨🇳 Hohhot, Inner Mongolia, China