Upper digestive tract disorder
Conditions
Interventions
None listed
Sponsors
Fukuoka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients undergoing upper gastrointestinal endoscopy, whether as an outpatient or inpatient (2) Patients who have received sufficient explanation and understanding of the study, and have given their free written consent to participate in the study. (3) Patients must be 20 years old or older and Japanese, regardless of gender.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the rate of achieving adequate sedation (anesthesia) depth after 5 minutes of administration of midazolam and flunitrazepam | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomomi Yamashima
University of Fukuoka gastroenterology
Outcome results
None listed