A Randomized, Controlled, Double-blind Trial of the Efficacy and Safety of CO2 vs Room Air Insufflation During Colonoscopy or ESD for Gastric Tumor
Phase 4
19 Years
85 Years
19 Years
85 Years
Not Enrolling
Both
Gastric Tumor
Both
Gastric Tumor
Trial Information
A Randomized, Controlled, Double-blind Trial of the Efficacy and Safety of CO2 vs Room Air Insufflation During Colonoscopy or ESD for Gastric Tumor
Inclusion Criteria:
- Patients who have gastroscopy and colonoscopy or ESD for gastric tumor under sedation
in department of gastroenterology, Gachon University Gil Medical Center
Exclusion Criteria:
- Age : < 19 years old
- Underlying disease : COPD requiring O2
- Known CO2 retention
- Opiate abuse for chronic pain
- Nonreader or short in understanding
- Pregnancy
- Any medical instabilities expected to not be in safe
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Outcome Measure:
Abdominal pain related to each insufflation
Outcome Description:
Patients will be received questionnaire (100mm visual analogue scale, VAS) and record their score in 0, 1, 3, 6, 24 hours after endoscopic procedure.
Outcome Time Frame:
1 day
Safety Issue:
Yes
Authority:
Korea: Institutional Review Board
Study ID:
GIRBA2681-2012
NCT ID:
NCT01579071
Start Date:
April 2012
Completion Date:
Related Keywords:
- Gastric Tumor
- Stomach Neoplasms
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