Gastric Adenoma, Gastric Cancer
Conditions
Keywords
gastric adenoma, early gastric cancer
Brief summary
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.
Interventions
parameter monitoring of bispectral index
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion
Exclusion criteria
* if they were under 18 years of age * had an ASA classification of 4-5 * were pregnant * had a history of stroke or an allergy to sedative drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD | within the one day after ESD |
Secondary
| Measure | Time frame |
|---|---|
| the dose of midazolam and meperidine during ESD with BIS monitoring | within one hour after ESD |
Countries
South Korea
Contacts
Primary ContactJae.J Kim, professor
Backup ContactKi Joo Kang, Dr
Outcome results
None listed