Efficacy and SafetyNCT06732427
Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment
A study testing fospropofol Disodium for injection and Propofol in people with Efficacy and Safety, run by Affiliated Hospital of Nantong University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- fospropofol Disodium for injection and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 5 sitesChina
- Study dates
- 12 Aug 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-65 years, weight 40-65kg, male or female;
- Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;
- American Society of Anesthesia (ASA) grades I-II;
- Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -
Who cannot join
- Patients with simple and painless gastroscopy
- Allergy to this study drug and any ingredients;
- Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
- Acute upper respiratory tract infection and asthma attacks;
- Liver and kidney insufficiency, abnormal heart function;
- History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;
- Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hai 'an People's Hospital
Hai’an, Jiangsu, 226600
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Qidong People's Hospital
Qidong, Jiangsu, 226200
Rudong County Hospital of Traditional Chinese Medicine
Rudong, Jiangsu, 226400
Rugao People's Hospital
Rugao, Jiangsu, 226500
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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
- Efficacy and Safety
- Being tested
- fospropofol Disodium for injection, Propofol
- Keywords
- Painless gastrointestinal endoscopy, fospropofol disodium for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fospropofol Disodium for injectionDrug
Also called sulfentanyl
Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)
PropofolDrug
Also called sulfentanyl
Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol Disodium | Experimental | Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection Receives: Drug: fospropofol Disodium for injection |
| propofol | Active comparator | Painless gastrointestinal endoscopy in group B was mainly performed using propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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. )
Measured: During anesthesia
hypoxaemia
Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)
Measured: During anesthesia
Secondary outcomes (5)
Hemodynamic index
The occurrence of hypotension, hypertension, bradycardia, and tachycardia
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: During anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start12 Aug 2025
- Primary completion30 Jan 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao MB Director of scientific research Department, Doctor, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732427
- Sponsor's protocol ID
- 2024-YCRF-M1021
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06732427
- Acronym / sponsor ID
- 2024-YCRF-M1021
- Conditions
- Efficacy and Safety
- Keywords
- Painless gastrointestinal endoscopy, fospropofol disodium for injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol Disodium | Experimental | Drug: fospropofol Disodium for injectionPainless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection |
| propofol | Active comparator | Drug: PropofolPainless gastrointestinal endoscopy in group B was mainly performed using propofol |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50-65 years, weight 40-65kg, male or female;
- Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;
- American Society of Anesthesia (ASA) grades I-II;
- Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -
Key exclusion criteria (7 listed)
- Patients with simple and painless gastroscopy
- Allergy to this study drug and any ingredients;
- Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
- Acute upper respiratory tract infection and asthma attacks;
- Liver and kidney insufficiency, abnormal heart function;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fospropofol Disodium for injectionAlso: sulfentanylGroup L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds) | Drug | Fospropofol Disodium |
| PropofolAlso: sulfentanylGroup B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds) | Drug | propofol |
Primary outcome
Sedation success rate
Time frame: 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
Time frame: 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
Time frame: During anesthesia
Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)
5 secondary outcomes
Hemodynamic index
Time frame: During anesthesia
Limb movements of the patient during the operation
Time frame: During anesthesia
Wake up time
Time frame: During anesthesia
Awakening quality of anesthesia
Time frame: 10 minutes ,20 minutes and 30 minutes after awakening
Total amount of study drug used
Time frame: During anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao MB Director of scientific research Department, Doctor principal investigator
Affiliated Hospital of Nantong University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fospropofol Disodium for injection and Propofol in people with Efficacy and Safety, run by Affiliated Hospital of Nantong University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation success rate (time frame: At 5 minutes after anesthetic administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.