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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

NCT03332433

Hypoxia Gastric Cancer Esophagus Cancer +1 more

COMPLETED NA

A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures

NCT07271303

Painless Gastrointestinal Endoscopy

NOT_YET_RECRUITING NA

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity

NCT04500392

Hypoxia Gastric Cancer Esophagus Cancer +2 more

RECRUITING NA

Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

NCT06713421

Esophageal Cancer Gastric Cancer

RECRUITING NA

Comparison of Using Regular or Rotary Polypectomy Snare for the Resection of Colorectal Polyps

NCT03608930

Polypectomy Snare

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Efficacy and Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Using a computer-generated randomized number table, the patients were divided into two groups: group L (fospropofol disodium group) and group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists. The study drug is prepared by someone who do not participate in the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fospropofol Disodium

Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection

Group Type EXPERIMENTAL

fospropofol Disodium for injection

Intervention Type DRUG

Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)

propofol

Painless gastrointestinal endoscopy in group B was mainly performed using propofol

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fospropofol Disodium for injection

Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)

Intervention Type DRUG

Propofol

Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sulfentanyl sulfentanyl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.-

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No