NCT02318199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

December 11, 2014

Last Update Submit

August 4, 2015

Conditions

Intensive Care, SurgicalPostoperative CareNeurosurgery

Keywords

emergence agitationintracranial surgerygeneral anesthesiaincidencerisk factor

Outcome Measures

Primary Outcomes (1)

  • Emergence agitation

    Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7.

    12 hours after operation

Study Arms (2)

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

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

Interventions

Anesthesia recovery after intracranial surgeryPROCEDURE

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

Agitation groupNon-agitation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients after craniotomy

You may qualify if:

  • Both supratentorial and infratentorial intradural cranial operations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Daxing Teaching Hospital, Capital Medical University

Beijing, Beijing Municipality, 102600, China

Location

Fujian Provincial Clinical College, Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

Bethune International Peace Hospital, Hebei Medical University

Shijiazhuang, Hebei, 050082, China

Location

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, 010017, China

Location

Related Publications (2)

  • 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.

    PMID: 30024979DERIVED

  • 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.

    PMID: 25900467DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

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 11, 2014

First Posted

December 17, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

CN(4)