What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Alfentanil Hydrochloride Injection, or Remimazolam Besylate for Injection. The registry lists allocation as randomized. This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients.
They plan to enroll about 120 people at Jinan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
ED₉₀ of Remimazolam Besylate Combined With Different Doses of Alfentanil for Inhibiting Gastroscopic Insertion Reactions in Obese Patients: A Dose-Finding Trial With Biased-Coin Sequential Allocation
Interventions: Alfentanil Hydrochloride Injection, Remimazolam Besylate for Injection
Primary outcome (registry wording): The primary outcome is the ED90 (90% effective dose) of remimazolam besylate combined with alfentanil for suppressing the gastroscopic insertion response in obese patients.