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

1. Research background: Painless endoscopic diagnosis and treatment technology refers to letting patients undergo various examinations and treatments in a comfortable and painless state, including painless gastrointestinal endoscopy, painless abortion, painless hysteroscopy, etc. These diagnosis and treatment operations are widely carried out in the outpatient department. The development of painless diagnosis and treatment technology has greatly improved the patient's satisfaction and comfort level. Anesthesia is the leading discipline of painless diagnosis and treatment technology. In recent years, the development of painless technology of intravenous general anesthesia and the selection of general anesthesia drugs have been controversial areas. It is very important to determine an appropriate anesthesia scheme.

It has been reported that the incidence of propofol in the diagnosis and treatment of painless gastroscopy reached 8.4%. For adult patients sedated by propofol, the dosage of propofol gradually decreased with the age of patients, and the incidence of hypoxemia increased, accompanied by the overall trend of increasing adverse cardiovascular events. To achieve rapid and predictable recovery requires stable intraoperative respiratory circulation, stable recovery, and reduced adverse reactions such as postoperative nausea, vomiting and injection pain, while propofol is easy to cause injection pain at the injection site of patients.

Fospropofol disodium for injection is an effective intravenous sedative hypnotic agent that was approved by the United States Food and Drug Administration (FDA) in December 2008 for adult anesthesia monitoring undergoing diagnosis or treatment process. It gradually releases the active metabolite propofol, with slow onset and more stable breathing and circulation. In 2021, the fospropofol disodium for injection copied by Yichang Renfu Pharmaceutical Co. Ltd. was approved by the human bioequivalence study (BE). The fospropofol disodium for injection developed by Chinese scholars is different from American scholars, with better drug structure and better drug specifications. Fospropofol disodium for injection is a chemical class 1 new drug, which is one of the most advanced systemic intravenous anesthetics studied at home and abroad.

In the Guidance on clinical Application of fospropofol disodium for injection published by the Chinese Journal of Anesthesiology, the indication has been approved as the induction of general anesthesia in adults. Phase Ⅲ clinical trials suggest that the efficacy of Fospropofol disodium for injection is more stable in the process of anesthesia induction to maintenance, and its efficacy duration is long, which can save the amount of subsequent sedative and analgesic drugs, meet the actual clinical needs and meet the requirements of pharmacoeconomics. In the pre-experiment, our research group found that 7.5 -8.5mg / kg fospropofol disodium for injection was used for anesthesia with painless gastrointestinal endoscopy, with definite effect, slight respiratory depression and stable hemodynamics. 2. The purpose of this study: Observe the safety and effectiveness of fospropofol disodium for injection in painless gastrointestinal endoscopic diagnosis and treatment, optimize the clinical anesthesia scheme, and provide reference for clinical medication for comfortable diagnosis and treatment. 3. Research method: 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. Mainly observe the success rate of sedation, total amount of fospropofol disodium for injection and propofol, additional doses, the occurrence of intraoperative hypoxemia, intraoperative circulatory system such as hypotension, hypertension, bradycardia, tachycardia, intraoperative adverse reactions such as reflex cough, intraoperative body movement, injection pain, postoperative recovery quality and other adverse reactions.

• Hemodynamic index [Срок оценки: During anesthesia]
• Limb movements of the patient during the operation [Срок оценки: During anesthesia]
• Wake up time [Срок оценки: During anesthesia]
• Awakening quality of anesthesia [Срок оценки: 10 minutes ,20 minutes and 30 minutes after awakening]
• Total amount of study drug used [Срок оценки: During anesthesia]