Unique ID issued by UMIN | UMIN000003841 |
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Receipt number | R000004627 |
Scientific Title | A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy |
Date of disclosure of the study information | 2010/06/29 |
Last modified on | 2014/12/23 15:15:02 |
A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
A multicenter randomized double blind test of the effect of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy
Japan |
Diseases in the gallbladder
Hepato-biliary-pancreatic surgery |
Others
NO
To evaluate the preventive efficacy of dexamethasone for post operative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy
Efficacy
Exploratory
Phase II
The incidence of post operative nausea and vomiting (PONV)
Postoperative complications, Postoperative hospital stay, Medical cost
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Intravenous administration of dexamethasone (8mg) just before cholecystectomy
Intravenous administration of saline just before cholecystectomy
20 | years-old | <= |
80 | years-old | > |
Male and Female
(1) Patient undergoing laparoscopic cholecystectomy
(2) Age between 20 and 79
(3) Adequate hematologic, hepatic, renal and respiratory function
(4) Written informed consent
(1) Emergency surgery
(2) Patient who had undergone upper abdominal surgery
(3) Patient who is expected to convert into open surgery
(4) Continuous use of steroid
(5) ASA>3
(6) Day surgery
(7) Treatment with opioid or tranquilizer within 1 week
(8) Clinically significant cardiac or respiratory dysfunction
(9) Severe mental disorder
(10) Contraindication for dexamethasone
(11) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial
270
1st name | |
Middle name | |
Last name | Hiroaki Nagano |
Osaka University Graduate school of Medicine
Department of Gastroenterological Surgery
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3251
1st name | |
Middle name | |
Last name | Hidetoshi Eguchi |
Osaka University Graduate school of Medicine
Department of Gastroenterological Surgery
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Multicenter Clinical Study Group of Osaka
None (Self-funding)
Self funding
NO
2010 | Year | 06 | Month | 29 | Day |
Unpublished
Completed
2010 | Year | 02 | Month | 18 | Day |
2010 | Year | 06 | Month | 01 | Day |
2013 | Year | 06 | Month | 19 | Day |
2013 | Year | 06 | Month | 19 | Day |
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 08 | Month | 01 | Day |
2010 | Year | 06 | Month | 29 | Day |
2014 | Year | 12 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004627
Research Plan | |
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Registered date | File name |
2014/12/24 | CSGO-HBP-002_LC後デキサメサゾン_プロトコル.docx |
Research case data specifications | |
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Registered date | File name |
2014/12/24 | CSGO-HBP-002_LC後デキサメサゾン_CRF.docx |
Research case data | |
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Registered date | File name |