A Phase 3 interventional study of bispectral index monitoring in Gastric Adenoma and Gastric Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-07-07.
Sponsored by Samsung Medical Center · Phase 3, Interventional, and Supportive care
Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 56 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: bispectral index monitoring
Device: bispectral index monitoring
parameter monitoring of bispectral index
the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD
Time frame: within the one day after ESD
the dose of midazolam and meperidine during ESD with BIS monitoring
Time frame: within one hour after ESD
This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center