Japanese patients undergoing gastrointestinal endoscopy in combination with a concomitant use of opi
Conditions
Interventions
After obtaining written consent, eligibility verification will be conducted and, in principle, enrollment will be conducted by the day before the scheduled date of investigational drug administration
Sponsors
Ikehara Hisatomo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese patients who are scheduled to undergo interventional endoscopy of the upper gastrointestinal tract (oral), large intestine, hepato-biliary-pancreas, or small intestine under the concomitant use of pethidine hydrochloride or pentazocine 2. The age at the time of obtaining consent is 20 years or older 3. BMI is less than 30kg/m2 4. Those whose planned procedure time (from scope insertion to final removal) that is determined by principal investigator or sub-investigator to be longer than 15 minutes 5. Those who can be hospitalized for at least 3 days from the day before the endoscopy to the day after the endoscopy
Exclusion criteria
Exclusion criteria: 1. Those who regularly use benzodiazepines (due to insomnia, anxiety, spasm, epilepsy, and others) or those who have tolerance to benzodiazepines 2. Those who regularly use analgesics including opioid analgesics (except low-dose aspirin for preventing thrombosis) 3. Those with a history of hypersensitivity to benzodiazepines, opioid analgesics, opioid antagonists (naloxone, levallorphan, and others), or flumazenil, or those with diseases or symptoms that contraindicate the administration of these drugs 4. Alcohol polydipsia (60g or more per day in terms of pure alcohol) or those with complications or a history of alcohol dependence 5. Those with a history of abdominal surgery and who are expected to have difficulty for scope insertion 6. Those with severe respiratory disease or essential hypotension 7. Among the clinical test measurement values within 28 days prior to administration of investigational drug, those that correspond to any of AST, ALT, and total bilirubin values that are 2.5 times or more of the upper limit of standard value (5 times or more in the case of patients undergoing hepato-biliary-pancreatic endoscopy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sedation in gastrointestinal endoscopy ("success" is defined when all of the following criteria are satisfied) 1.Sedation (MOAA/S score 3 or less) can be obtained before the start of endoscopy. 2.Successful completion of gastrointestinal endoscopy 3. The number of additional doses does not exceed 5 times per 15 minutes after the start of endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Percentage of subjects who achieved sedation before the start of endoscopy -Time from initial administration of investigational drug to sedation -Dose of investigational drug until sedation is obtained (total dose of investigational drug until start of endoscopy) -Presence or absence of memory during endoscopy -Total dose and the number of administrations of essential concomitant analgesics -Time from the end of the endoscopy until the patient is determined to be able to leave the endoscopy room -Time from the last dose of investigational drug until the patient is determined to be able to leave the endoscopy room | — |
Contacts
Public ContactClinical Trial Coordinating Office
Cmic Co., Ltd.
Outcome results
None listed