Clinical trials on sedation for endoscopy
Not Applicable
- Conditions
- pper digestive tract disorder
- Registration Number
- JPRN-UMIN000046864
- Lead Sponsor
- Fukuoka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 355
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with a history of allergy to sedatives (2) Patients with hepatic cirrhosis or dialysis that may affect metabolism. (3) Patients suffering from psychiatric disorders that may affect the sedative effect and patients taking two or more psychotropic drugs. (4) Women who are pregnant, lactating, or who wish to become pregnant during the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the rate of achieving adequate sedation (anesthesia) depth after 5 minutes of administration of midazolam and flunitrazepam
- Secondary Outcome Measures
Name Time Method 1) Correlation between depth of sedation (anesthesia) and blood concentration of drugs 2) Correlation between depth of sedation (anesthesia) and genetic polymorphisms of drug metabolizing enzymes, MDR1 and GABRA1 3) Correlation of drug metabolizing enzymes, MDR1 and GABRA1 gene polymorphisms with depression 4) Comparison of cardiovascular and respiratory status between midazolam and flunitrazepam 5) Correlation of blood drug concentrations between midazolam and flunitrazepam 6) Comparison of patient satisfaction between midazolam and flunitrazepam 7) Comparison of recovery time between midazolam and flunitrazepam 8) Safety 9) Frequency of depression and side effects