UMIN ID: UMIN000001497
Registered date:11/11/2008
Midazolam v.s. propofol for sedaion in endoscopic submucosal dissection; a randomized phase II trial. KDOG0801
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | early gastric cancer, gastric adenoma |
| Date of first enrollment | 2008/07/01 |
| Target sample size | 138 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | sedation with propofol sedation with midazolam |
Outcome(s)
| Primary Outcome | the efficacy of sedation enough for endoscopic submucosal dissection. |
|---|---|
| Secondary Outcome | the safety of sedation during endoscopic submucosal dissection. the sagety of sadation after endoscopic submucosal dissection. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | ASA classification:above III. severe disease in heart, lung, liver, or kidney. allergic episode with midazolam or propofol. women in pregnancy or breast-feeding any other reasosn by which docter judged inappropriate case. |
Related Information
| Primary Sponsor | Kitasato Digestive disease and Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kitasato University East hospital Department of gastroenterology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tohru SASAKI |
| Address | Asamizodai2-1-1, Sagamihra, Kanagawa Japan |
| Telephone | 042-748-9111 |
| tohrus@t3.rim.or.jp | |
| Affiliation | Kitasato University East Hospital Department of gastroenterology |
| scientific contact | |
| Name | Satoshi TANABE |
| Address | Asamizodai2-1-1,Sagamihara, Kanagawa Japan |
| Telephone | 042-748-9111 |
| Affiliation | Kitasato University East Hospital Department of gastroenterology |