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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000007204
Date of registration: 02/02/2012
Prospective Registration: No
Primary sponsor: National Center for Geriatrics and Gerontology
Public title: A study on the aggravation prophylaxis of postoperative delirium for the elderly
Scientific title: A study on the aggravation prophylaxis of postoperative delirium for the elderly - A study on the aggravation prophylaxis of postoperative delirium for the elderly
Date of first enrolment: 2012/02/01
Target sample size: 180
Recruitment status: Complete: follow-up complete
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008480
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:     Shinji Fukata
Address:  Gengo 35, Morioka-cho, Obu-city, Aichi, Japan Japan
Telephone: 0562-46-2311
Email: fukatash@ncgg.go.jp
Affiliation:  National Center for Geriatrics and Gerontology Department of Perioperative Medical Care
Name:     Shinji Fukata
Address:  Gengo 35, Morioka-cho, Obu-city, Aichi, Japan Japan
Telephone: 0562-46-2311
Email: fukatash@ncgg.go.jp
Affiliation:  National Center for Geriatrics and Gerontology Department of Perioperative Medical Care
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: A patient with emergency surgery. The case whose NEECHAM score is less than 19.

Age minimum: 75years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
postoperative delirium
Intervention(s)
In the intervention group, Haloperidol 5mg intravenous drip infusion will be performed from postoperative day 0 to 5, when the NEECHAM score is 20 to 24. When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
Only serial obsevations will be applied to the control group. When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
Primary Outcome(s)
We chase psychological disorders / abnormal behavior assessment with NEECHAM score from preoperative day to postoperative day 10 consecutively.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
National Center for Geriatrics and Gerontology(Independent administative agency)
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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