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

Not Applicable

Not yet recruiting

• Conditions: Efficacy and Safety
• Interventions: Drug: fospropofol Disodium for injection; Drug: Propofol

• Registration Number: NCT06732427
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Study Start: 2025-03-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 426

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.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fospropofol Disodium	fospropofol Disodium for injection	Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection
propofol	Propofol	Painless gastrointestinal endoscopy in group B was mainly performed using propofol

Primary Outcome Measures

Name	Time	Method
Sedation success rate	At 5 minutes after anesthetic administration	Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1(The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64( The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )within 5 minutes (no additional drug within 5 minutes)
Length of successful induction of anesthesia	During anesthesia	Time from the first start of administration of study drug to Modified Observer's Assessment of Alertness/Sedation score ≤1 ((The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64(The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )
hypoxaemia	During anesthesia	Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)

Secondary Outcome Measures

Name	Time	Method
Limb movements of the patient during the operation	During anesthesia	No movement of limbs (10 points); slight movement, occasionally (8 points); slight movement, frequent (6 points), vigorous movement, arms and legs only (4 points); vigorous body and head movement (2 points)
Wake up time	During anesthesia	Time from the end of surgery until Modified Observer's Assessment of Alertness/Sedation score=5 points(The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome).
Hemodynamic index	During anesthesia	The occurrence of hypotension, hypertension, bradycardia, and tachycardia
Awakening quality of anesthesia	10 minutes ,20 minutes and 30 minutes after awakening	Wake quality was assessed using a modified AIdrete score(The rating scale ranges from levels 0 to 10, and the lower the score indicates that the worse the recovery mass, namely a higher scores mean a better outcome).
Total amount of study drug used	During anesthesia	Total dosage of fospropofol disodium and propofol for injection, and number of additional doses

Trial Locations

Locations (1)

Yongtao Gao; 🇨🇳 Nantong, Jiangsu, China