UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006788 |
|---|---|
| Receipt number | R000008034 |
| Scientific Title | Can therapeutic intervention to the decrease of cerebral regional oxygen saturation during abdominal surgery prevent the occurrence of postoperative cognitive dysfunction in elderly patients? |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2015/01/12 23:02:51 |
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Basic information
Public title
Can therapeutic intervention to the decrease of cerebral regional oxygen saturation during abdominal surgery prevent the occurrence of postoperative cognitive dysfunction in elderly patients?
Acronym
Does therapeutic intervention to cerebral hypoxia improve the postoperative cognitive dysfunction?
Scientific Title
Can therapeutic intervention to the decrease of cerebral regional oxygen saturation during abdominal surgery prevent the occurrence of postoperative cognitive dysfunction in elderly patients?
Scientific Title:Acronym
Does therapeutic intervention to cerebral hypoxia improve the postoperative cognitive dysfunction?
Region
| Japan |
Condition
Condition
Diseases requiring abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of therapeutic intervention to the decrease of cerebral oxygen saturation on postoperative cognitive dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of mini mental state examination (MMSE) test
Key secondary outcomes
Bispectral index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Increase of inspiratory oxygen concentration
Interventions/Control_2
none
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with American Society of Anesthesiologists Classification I - III scheduled for undergoing elective abdominal surgery requiring more than 2 hours.
Key exclusion criteria
Patients with a history of cerebral ischemia, cerebral infarction or score of mini mental state examination less than 23, hospital stay within 3 days.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
ryuokutani0909@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital and Children's Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22, Miyakojimahondori, Miyakojma-ku, Osaka 534-0021, Japan
TEL
81-6-6929-1221
Homepage URL
ryuokutani0909@ybb.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City General Hospital and Children's Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In elderly patients (n = 63), laparotomy or laparoscopic surgery did not induce cognitive function disorder after surgery. Body position or pneumoperitoneum did not affect cognitive function after surgery.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 29 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008034
