Unique ID issued by UMIN | UMIN000005423 |
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Receipt number | R000006439 |
Scientific Title | Examination of effect of yokukansan in prevention of the delirium after the surgical operation. |
Date of disclosure of the study information | 2011/04/12 |
Last modified on | 2016/06/01 09:09:39 |
Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Examination of effect of yokukansan in prevention of the delirium after the surgical operation.
Japan |
Gastrointestinal cancer
Lung cancer
Surgery in general | Gastrointestinal surgery | Chest surgery |
Malignancy
NO
We examine the effect of the yokukansan ,which is administered before and after the surgery, in prevention of the delirium after the surgical operation.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Incidence of delirium after the operation
safety
Hospital days after the operation
Severity of symptoms of delirium
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
Central registration
2
Treatment
Medicine |
yokukansan administering group
yokukansan non-administering group
70 | years-old | <= |
Not applicable |
Male and Female
1)Patients undergoing elective surgery for gastrointestinal cancer or lung cancer.
2)Patients aged over 70.
3)ECOG Performance status is 0 to 2
4)Patient who is not scheduled to enter ICU after the operation.
5)Major organ function is preserved.
6)Witten informed consent is taken.
1)Prior therapy with major tranquilizer within the past 6 months.
2)Serious complications due to psychological illness.
3)Uncontrollable heart disease.
4)Chronic renal failure or renal disfunction(Cr>=1.5 mg/dl).
5)Patients judged to be inappropriate by doctor in charge.
220
1st name | |
Middle name | |
Last name | Yasushi Rino |
Yokohama City University
general surgery
3-9Fukuura,Kanazawa-ku,Yokohama City,236-0004,Japan
045-787-2645
rino@med.yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Nobuhiro Sugano |
Yokohama City University
general surgery
3-9Fukuura,Kanazawa-ku,Yokohama City,236-0004,Japan
045-261-5656
suga_p1012@yahoo.co.jp
Department of surgery,yokohama city university
None
Self funding
NO
神奈川県立足柄上病院(神奈川県)
国際医療福祉大学 熱海病院(静岡県)
国家公務員共済組合連合会 平塚共済病院(神奈川県)
国家公務員共済組合連合会 南共済病院(神奈川県)
国家公務員共済組合連合会 横須賀共済病院(神奈川県)
総合病院 秦野赤十字病院(神奈川県)
藤沢湘南台病院 (神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
2011 | Year | 04 | Month | 12 | Day |
Unpublished
Completed
2011 | Year | 04 | Month | 12 | Day |
2011 | Year | 04 | Month | 01 | Day |
2016 | Year | 09 | Month | 30 | Day |
2011 | Year | 04 | Month | 12 | Day |
2016 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006439
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