drugset / Trial / NCT05518929

Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients

NCT05518929

RandomizedParallel-groupOpen-labelTreatment

Summary

Ciprofol is a new general anesthetic, which combine with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in the sedation for gastrointestinal endoscopy, especially for overweight and obese patients. We conduct a Multicenter, Randomized, Open-label, Propofol-controlled Study to Evaluate the incidence of hypoxia and severe hypoxia during Gastroenterological Endoscope sedated with CiProfol in Overweight or Obesity patients.

Timeline

Start
2022-09-08
Primary completion
2023-08-15
Completion
2023-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.2 mg/kg
Comparator Propofol Small molecule 0.75 mg/kg