Study on Safety and Effectiveness of Fospropofol Disodium Compared to Propofol for Painless Gastrointestinal Endoscopy in Adults Aged 50 to 65

What this Trial Is About

Researchers are evaluating the efficacy and safety of fospropofol disodium for injection during painless endoscopic diagnosis and treatment, including gastrointestinal endoscopy and colonoscopy, in adults aged 50 to 65 years. This multicenter, randomized, double-blind, controlled clinical study compares fospropofol disodium with propofol to find an appropriate anesthesia method that improves patient comfort, stabilizes anesthesia induction, and reduces adverse events like hypoxemia and cardiovascular complications. Participants are randomly assigned to one of two groups one receives slow intravenous sufentanyl plus fospropofol disodium at 8 mgkg completed within 60 seconds, and the other receives slow intravenous sufentanyl plus propofol at 2 mgkg completed within 60 seconds. Two fixed anesthesiologists administer the drugs. The study focuses on sedation success, anesthesia induction duration, and incidence of hypoxemia, among other safety and effectiveness measures. During the trial, participants undergo painless gastrointestinal procedures while researchers monitor sedation success, total drug doses, intraoperative vital signs, body movements, injection pain, and recovery quality at intervals up to 30 minutes after awakening. The study also tracks hemodynamic stability and adverse reactions to assess the overall safety profile. The total study duration exceeds two years, with careful follow-up to support rapid recovery and reduce hospitalization costs.

Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment