Delirium, PostoperativeNCT01032161
Perioperative Risk Factors for Postoperative Delirium in Children
An observational study of Delirium, Postoperative, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Delirium, Postoperative
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Dec 2012
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients between 3 to 12 years old, who were admitted to the PACU after elective non-cardiac surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)
Who may be able to join
- between 3 to 12 years old
- elective non-cardiovascular surgery
- general anesthesia
Who cannot join
- under regional anaesthesia
- instable vital sign
- without consent form
- underwent neurosurgery
- history of primary neurologic diseases
- stayed less than 10min in PACU
- received general anaesthesia but recovered in locations outside the recovery room
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia
Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among children undergoing non cardiovascular surgery.
Read the detailed description
Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Postoperative, Non-cardiovascular surgery, Post-anaesthesia care unit, patients between 3 to 12 years old, undergoing selective non-cardiac surgery, under general anesthesia, surgery, general anesthesia
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delirium | Delirium was determined by RASS-PAEDS | |
| no Delirium | no Delirium was determined by RASS-PAEDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria
Measured: at 1, 8, 16, 24, 48 and 72 postoperative hour
Secondary outcomes (5)
Maximal and minimal heart rate in PACU
Measured: every 15 min during PACU stay
Pulse Oximeter Oxygen Saturation (SpO2) in PACU
Measured: every 15 min during PACU stay
Hospital-length of stay
Measured: before discharge
Total health care fees
Measured: during hospital stay
Quality of recovery measured by PACBIS criteria
Measured: at 1, 8, 16, 24, 48 and 72 postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Chuanhan Zhang, M.D., Study director, Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyYuke Tian, M.D., Study chair, Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032161
- Sponsor's protocol ID
- TIHMZK02002
- Status last verified
- Feb 2013
- First submitted
- 14 Dec 2009
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia
- ClinicalTrials.gov ID
- NCT01032161
- Acronym / sponsor ID
- TIHMZK02002
- Conditions
- Delirium, Postoperative
- Keywords
- Delirium, Postoperative, Non-cardiovascular surgery, Post-anaesthesia care unit, patients between 3 to 12 years old, undergoing selective non-cardiac surgery, under general anesthesia, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Dec 2009 (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.
Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among children undergoing non cardiovascular surgery.
Detailed description
Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium | – | –Delirium was determined by RASS-PAEDS |
| no Delirium | – | –no Delirium was determined by RASS-PAEDS |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients between 3 to 12 years old, who were admitted to the PACU after elective non-cardiac surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)
Key inclusion criteria (3 listed)
- between 3 to 12 years old
- elective non-cardiovascular surgery
- general anesthesia
Key exclusion criteria (7 listed)
- under regional anaesthesia
- instable vital sign
- without consent form
- underwent neurosurgery
- history of primary neurologic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria
Time frame: at 1, 8, 16, 24, 48 and 72 postoperative hour
5 secondary outcomes
Maximal and minimal heart rate in PACU
Time frame: every 15 min during PACU stay
Pulse Oximeter Oxygen Saturation (SpO2) in PACU
Time frame: every 15 min during PACU stay
Hospital-length of stay
Time frame: before discharge
Total health care fees
Time frame: during hospital stay
Quality of recovery measured by PACBIS criteria
Time frame: at 1, 8, 16, 24, 48 and 72 postoperative hour
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 26 Feb 2013.
Related trials for Delirium, Postoperative
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Chuanhan Zhang, M.D. study director
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Yuke Tian, M.D. study chair
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, Postoperative, run by Huazhong University of Science and Technology at 1 site 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 3 inclusion and 7 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 26 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria (time frame: at 1, 8, 16, 24, 48 and 72 postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2013.