Patients undergoing esophagogastroduodenoscopy (EGD) for screening or diagnostic purposes
Conditions
Interventions
None listed
Sponsors
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 20 years or older with opt-out consent obtained. Underwent EGD for screening or diagnostic purposes with RMZ as the sedative. Had an EGD under PRO monotherapy (opioid-free) at our institution within the past 2 years, completed without scope change. Procedures performed by an expert endoscopist (board-certified gastroenterologist with >= 2,000 EGD experience), or a physician whose skill level is considered equivalent to an expert, in both prior and current examinations.
Exclusion criteria
Exclusion criteria: Patients with changes in ASA Physical Status (ASA PS) classification between the previous and current examinations. Patients with differences in gastric anatomy due to surgical procedures between the previous and current examinations. Patients with a history of surgical treatment of the esophagus, stomach, or duodenum. Patients undergoing upper gastrointestinal endoscopic ultrasound (EUS). Use of pharyngeal anesthesia in either the previous or current examination. Patients undergoing emergency endoscopy. Women who are pregnant or may be pregnant. Patients receiving opioids (including tramadol). Other patients judged unsuitable for the study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equipotent Dose Ratio calculated from the total dose per body weight (mg/kg) in cases that completed EGD while maintaining the target sedation depth (MOAA/S<=3) without concomitant use of other sedatives, analgesics, or flumazenil. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1: Dose-response model estimation: Estimation of ED50 (50% effective dose) and ED95 (95% effective dose) for RMZ and PRO 2: Recovery time: Rate of achieving Modified Aldrete score >=9 (discharge criteria) within 30 minutes of procedure completion 3: Safety: Incidence of respiratory depression, bradycardia, and disinhibition; rate of use of additional sedatives and reversal agents (flumazenil) | — |
Countries
Japan
Contacts
Public ContactYutaka Eto
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan. Department of Gastroenterology.
Outcome results
None listed