Emergence Agitation in Adult Patients After Intracranial Surgery

Sponsor

Capital Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02318199

Collaborator

Beijing Municipal Administration of Hospital, China (Other)

400

Enrollment

Locations

Duration (Months)

100

Patients Per Site

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care, Surgical Postoperative Care Neurosurgery	Procedure: Anesthesia recovery after intracranial surgery

Study Design

Study Type:

Observational

Actual Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Agitation group 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.	Procedure: Anesthesia recovery after intracranial surgery Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.
Non-agitation group 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.	Procedure: Anesthesia recovery after intracranial surgery Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.

Arm

Intervention/Treatment

Agitation group

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.

Procedure: Anesthesia recovery after intracranial surgery

Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.

Non-agitation group

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.

Procedure: Anesthesia recovery after intracranial surgery

Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daxing Teaching Hospital, Capital Medical University	Beijing	Beijing	China	102600
2	Fujian Provincial Clinical College, Fujian Medical University	Fuzhou	Fujian	China	350001
3	Bethune International Peace Hospital, Hebei Medical University	Shijiazhuang	Hebei	China	050082
4	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia	China	010017