Unique ID issued by UMIN | UMIN000012365 |
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Receipt number | R000014454 |
Scientific Title | Preventing postoperative nausea and vomiting, effect of dexametasone |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2020/05/16 11:48:20 |
Preventing postoperative nausea and vomiting, effect of dexametasone
Preventing postoperative nausea and vomiting , effect of dexametasone
Preventing postoperative nausea and vomiting, effect of dexametasone
Preventing postoperative nausea and vomiting , effect of dexametasone
Japan |
postoperative nausea and vomiting
Breast surgery |
Malignancy
NO
preventing postoperative nausea and vomiting
Efficacy
incidence of PONV
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
No treatment
NO
NO
2
Treatment
Medicine |
dexametasone and saline
saline alone
20 | years-old | <= |
70 | years-old | > |
Female
Patient of breast cancer
patients with a history of drug allergy,
diabetes control was unfavorable,
dexamethasone was contraindicated,
patients received opioids before surgery,
patients underwent autologous breast reconstruction.
200
1st name | Masako |
Middle name | |
Last name | Sakuragi |
Jichi Medical University
breast surgery
329-0498
Yakushiji 3311-1, Simotsuke city, Tochigi prefecture, Japan
0285-44-2111
masako@omiya.jichi.ac.jp
1st name | Masako |
Middle name | |
Last name | Sakuragi |
Jichi medical university
breast surgery
329-0498
Yakushiji 3311-1, Simotsuke city, Tochigi prefecture, Japan
0285-44-2111
masako@omiya.jichi.ac.jp
Jichi medical university, department of breast surgery, department of Anesthegiology
none
Other
Jichi Medical University
3311-1, Yakushiji, Shimotsuke city, Tochigi, Japan
0285-44-2111
masako@omiya.jichi.ac.jp
NO
2013 | Year | 12 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014454
Partially published
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014454
208
Informed consent was obtained from 208 patients between December 2013 and August 2015. Thirteen patients who withdrew from this study, 23 in whom the contents of anesthesia were changed, and 2 who underwent additional surgery due to postoperative hemorrhage were excluded from analysis. Finally, 170 patients (Group D: 85, Group S: 85) were analyzed. PONV was observed in 27 patients (31.7%) in Group D and in 26 (30.6%) in Group S. There was no significant difference between the two groups (p=0.868).
2020 | Year | 05 | Month | 16 | Day |
The subjects were primary breast cancer patients, aged 20 to 69 years, who underwent surgery in our hospital.
After informed consent was obtained, the patients were assigned to receive dexamethasone (Group D) or physiological saline (Group S) through randomization with the table of random numbers.
No patients had any adverse events.
The presence or absence of PONV within 48 hours after surgery was established.
Completed
2013 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 05 | Day |
2017 | Year | 05 | Month | 30 | Day |
2017 | Year | 05 | Month | 30 | Day |
2017 | Year | 10 | Month | 31 | Day |
2017 | Year | 10 | Month | 31 | Day |
2013 | Year | 11 | Month | 20 | Day |
2020 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014454
Research Plan | |
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Registered date | File name |
2020/05/16 | PONVプロトコール最終提出分.doc |
Research case data specifications | |
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Registered date | File name |
2020/05/16 | 症状経過票②.doc |
Research case data | |
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Registered date | File name |
2020/05/16 | PONV試験解析結果公開.xlsx |