Emergence Agitation in Adult Patients After Intracranial Surgery

NCT ID: NCT02318199

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Intensive Care, Surgical Postoperative Care Neurosurgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Anesthesia recovery after intracranial surgery

Intervention Type PROCEDURE

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.

Anesthesia recovery after intracranial surgery

Intervention Type PROCEDURE

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

Interventions

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Anesthesia recovery after intracranial surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Administration of Hospital, China

UNKNOWN

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-Xin Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Daxing Teaching Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Fujian Provincial Clinical College, Fujian Medical University

Fuzhou, Fujian, China

Site Status

Bethune International Peace Hospital, Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Site Status

Countries

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China

References

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Huang HW, Yan LM, Yang YL, He X, Sun XM, Wang YM, Zhang GB, Zhou JX. Bi-frontal pneumocephalus is an independent risk factor for early postoperative agitation in adult patients admitted to intensive care unit after elective craniotomy for brain tumor: A prospective cohort study. PLoS One. 2018 Jul 19;13(7):e0201064. doi: 10.1371/journal.pone.0201064. eCollection 2018.

Reference Type DERIVED
PMID: 30024979 (View on PubMed)

Yan LM, Chen H, Yu RG, Wang ZH, Zhou GH, Wang YJ, Zhang X, Xu M, Chen L, Zhou JX; Acute Brain Injury and Critical Care Research Collaboration (ABC Research Collaboration). Emergence agitation during recovery from intracranial surgery under general anaesthesia: a protocol and statistical analysis plan for a prospective multicentre cohort study. BMJ Open. 2015 Apr 21;5(4):e007542. doi: 10.1136/bmjopen-2014-007542.

Reference Type DERIVED
PMID: 25900467 (View on PubMed)

Other Identifiers

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KY2014-034-01

Identifier Type: -

Identifier Source: org_study_id

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