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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorAffiliated Hospital of Nantong University

About this trial

This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.

This is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.

Eligibility criteria

Qualifiers

Age 50-65 years, weight 40-65kg, male or female;

Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;

American Society of Anesthesia (ASA) grades I-II;

Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -

Disqualifiers

Patients with simple and painless gastroscopy

Allergy to this study drug and any ingredients;

Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;

Acute upper respiratory tract infection and asthma attacks;

Trial design

Treatments tested in this trial

  • fospropofol Disodium for injection
  • Propofol

Treatment groups

426 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Affiliated Hospital of Nantong University

Lead sponsor

Rugao People's Hospital

Collaborator

Qidong People's Hospital

Collaborator

Hai 'an People's Hospital

Collaborator

Rudong County Hospital of Traditional Chinese Medicine

Collaborator