Intensive Care, SurgicalNCT02318199
Emergence Agitation in Adult Patients After Intracranial Surgery
An observational study of Intensive Care, Surgical and Postoperative Care, run by Capital Medical University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intensive Care, Surgical, Postoperative Care, Neurosurgery
- What is being tested?
- Anesthesia recovery after intracranial surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2015to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients after craniotomy
Who may be able to join
- Both supratentorial and infratentorial intradural cranial operations
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Daxing Teaching Hospital, Capital Medical University
Beijing, Beijing Municipality, 102600
Fujian Provincial Clinical College, Fujian Medical University
Fuzhou, Fujian, 350001
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010017
Bethune International Peace Hospital, Hebei Medical University
Shijiazhuang, Hebei, 050082
About this study
Official title: Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study
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.
- Conditions
- Intensive Care, Surgical, Postoperative Care, Neurosurgery
- Being tested
- Anesthesia recovery after intracranial surgery
- Keywords
- emergence agitation, intracranial surgery, general anesthesia, incidence, risk factor
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia recovery after intracranial surgeryProcedure or surgery
Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Anesthesia recovery after intracranial surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7.
Measured: 12 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care, SurgicalStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318199
- Sponsor's protocol ID
- KY2014-034-01
- Status last verified
- Aug 2015
- First submitted
- 11 Dec 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30024979Yan 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.
PubMed 25900467
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT02318199
- Acronym / sponsor ID
- KY2014-034-01
- Conditions
- Intensive Care, Surgical, Postoperative Care, Neurosurgery
- Keywords
- emergence agitation, intracranial surgery, general anesthesia, incidence, risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agitation group | – | Procedure: Anesthesia recovery after intracranial surgeryPatient 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 | – | Procedure: Anesthesia recovery after intracranial surgeryPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients after craniotomy
Key inclusion criteria (1 listed)
- Both supratentorial and infratentorial intradural cranial operations
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia recovery after intracranial surgeryIntracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection. | Procedure or surgery | Agitation group, Non-agitation group |
Primary outcome
Emergence agitation
Time frame: 12 hours after operation
Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Derived from this study: PubMed 30024979Huang 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.
- Derived from this study: PubMed 25900467Yan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD principal investigator
Beijing Tiantan Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care, Surgical and Postoperative Care, run by Capital Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence agitation (time frame: 12 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.