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

Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy and Safety
• Intervention / Treatment: Drug: fospropofol Disodium for injection; Drug: Propofol

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 Type: Interventional
• Enrollment (Estimated): 426
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu YF project implementation PI, Master; Phone Number: +86 13506289927; Email: winters_cool@126.com
• Study Contact Backup: Name: Gao YT Director of Department of Anesthesiology, Master; Phone Number: +86 13962988003; Email: gyt19700114@sina.com

Study Locations

• China
  • Jiangsu
    • Hai’an, Jiangsu, China, 226600
      • Recruiting
      • Hai 'an People's Hospital
      • Contact: Wang X Director of the Department of Anesthesiology, undergraduate course; Phone Number: +86 15962784599; Email: 2476614177@qq.com
      • Contact: Zhou XL The branch center implements PI, Master; Phone Number: +8615006277562; Email: 389450261@qq.com
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Gao YT Director of the Department of Anesthesiology, Master; Phone Number: 13962988003; Email: gyt19700114@sina.com
      • Contact: Liu YF The branch center implements PI, Master; Phone Number: 13506289927; Email: winters_cool@126.com
    • Qidong, Jiangsu, China, 226200
      • Not yet recruiting
      • Qidong People's Hospital
      • Contact: Yin YS Director of Anesthesiology, Qidong People's Hospital, undergraduate course; Phone Number: +86 13338095800; Email: 13338095800@189.com
      • Contact: Kuai J The branch center implements PI, undergraduate course; Phone Number: +86 13358090601; Email: 821310027@qq.com
    • Rudong, Jiangsu, China, 226400
      • Recruiting
      • Rudong County Hospital of Traditional Chinese Medicine
      • Contact: Chen J Director of the Department of Anesthesiology, undergraduate course; Phone Number: +86 13862783566; Email: 40237900@qq.com
      • Contact: Miao MR The branch center implements PI, undergraduate course; Phone Number: +8615251318831; Email: 749968267@qq.com
    • Rugao, Jiangsu, China, 226500
      • Recruiting
      • Rugao People's Hospital
      • Contact: Yang XL Director of Anesthesiology, Rugao People's Hospital, undergraduate course; Phone Number: +86 13861927678; Email: yangxiaolinrugao@163.com
      • Contact: Cong F The branch center implements PI, undergraduate course; Phone Number: 15050636051; Email: 393344043@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fospropofol Disodium; Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection	Drug: fospropofol Disodium for injection; Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds); Other Names: sulfentanyl
Active Comparator: propofol; Painless gastrointestinal endoscopy in group B was mainly performed using propofol	Drug: Propofol; Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds); Other Names: sulfentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation success rate	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)	At 5 minutes after anesthetic administration
Length of successful induction of 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. )	During anesthesia
hypoxaemia	Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)	During anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic index	The occurrence of hypotension, hypertension, bradycardia, and tachycardia	During anesthesia
Limb movements of the patient during the operation	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)	During anesthesia
Wake up time	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).	During anesthesia
Awakening quality of anesthesia	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).	10 minutes ,20 minutes and 30 minutes after awakening
Total amount of study drug used	Total dosage of fospropofol disodium and propofol for injection, and number of additional doses	During anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General data of the patient(1)	age	Preoperative and intraoperative
General data of the patient(2)	height	Preoperative and intraoperative
General data of the patient(3)	weight	Preoperative and intraoperative
General data of the patient(4)	Other general data, including gender, current medical history, history of combined diseases and medication allergy, history of hypertension / diabetes (most hypertension / blood glucose, type and age of medication, and presence of other organs); mouth opening, the history of snoring, history of Obstructive sleep apnea and hypopnea syndrome, number of shots of gastrointestinal endoscopy, basic blood oxygen value	Preoperative and intraoperative
Perioperative adverse effects	Including intraoperative awareness, injection pain, nausea, vomiting, itching, and paraesthesia	up to 24 hours after surgery
Evaluation of patient satisfaction with anesthesia	The rating scale ranges from levels dissatisfaction, basic satisfaction, satisfaction to very satisfaction, the higher scores mean a better outcome.	up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Collaborators: Qidong People's Hospital; Rugao People's Hospital; Rudong County Hospital of Traditional Chinese Medicine; Hai 'an People's Hospital
• Investigators: Principal Investigator: Xiao MB Director of scientific research Department, Doctor, The Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Painless gastrointestinal endoscopy; fospropofol disodium for injection
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Administration Routes; Drug Therapy; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Fentanyl; Propofol; Sufentanil; Injections; fospropofol
• Other Study ID Numbers: 2024-YCRF-M1021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No