Clinical trial NCT06732427: Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
Official title: Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Efficacy and Safety
Keywords: Painless gastrointestinal endoscopy
fospropofol disodium for injection
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 426
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 50-65 years, weight 40-65kg, male or female;
2. Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;
3. American Society of Anesthesia (ASA) grades I-II;
4. Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -

Exclusion Criteria:

1. Patients with simple and painless gastroscopy
2. Allergy to this study drug and any ingredients;
3. Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
4. Acute upper respiratory tract infection and asthma attacks;
5. Liver and kidney insufficiency, abnormal heart function;
6. History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;
7. Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-

Primary outcomes:
measure: Sedation success rate
timeFrame: At 5 minutes after anesthetic administration
measure: Length of successful induction of anesthesia
timeFrame: During anesthesia
measure: hypoxaemia
timeFrame: During anesthesia
Secondary outcomes:
measure: Hemodynamic index
timeFrame: During anesthesia
measure: Limb movements of the patient during the operation
timeFrame: During anesthesia
measure: Wake up time
timeFrame: During anesthesia
measure: Awakening quality of anesthesia
timeFrame: 10 minutes ,20 minutes and 30 minutes after awakening
measure: Total amount of study drug used
timeFrame: During anesthesia
Other outcomes:
measure: General data of the patient(1)
timeFrame: Preoperative and intraoperative
measure: General data of the patient(2)
timeFrame: Preoperative and intraoperative
measure: General data of the patient(3)
timeFrame: Preoperative and intraoperative
measure: General data of the patient(4)
timeFrame: Preoperative and intraoperative
measure: Perioperative adverse effects
timeFrame: up to 24 hours after surgery
measure: Evaluation of patient satisfaction with anesthesia
timeFrame: up to 24 hours after surgery
Locations:
city: Nantong
country: China
facility: Yongtao Gao
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Nantong University
name: Xiao MB Director of scientific research Department, Doctor
role: PRINCIPAL_INVESTIGATOR
References: