Drug SafetyPhase 4NCT06573489
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
A Phase 4 study testing Fospropofol and Propofol in people with Drug Safety, run by Hui Xu at 1 site in China.
Trial summary
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Safety
- What is being tested?
- Fospropofol and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age (18-65 years old)
- ASA（American Society of Anesthesiologists）grade I~II
- The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned
- BMI value 18-30kg /m2
- Voluntary signing of informed consent
Who cannot join
- Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
- Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;
- Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)
- uncontrolled diabetes or high blood pressure;
- A history of drug use, alcoholism or drug dependence;
- Abuse or long-term use of narcotic, sedative and analgesic drugs;
Show all 11Show fewer
- Those who are known or suspected to be allergic to or contraindicated by the process administration of various components or protocols of the study drug (sufentanil citrate injection, propofol medium/long chain fat milk, remifentanil hydrochloride for injection, and propofol disodium for injection);
- People with a history of mental illness;
- Participants in any drug clinical trial within 1 month before screening;
- Pregnant and lactating women; The reluctance of fertile women or men to use contraception throughout the trial; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
- Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Hui Xu, +8613971001596, huixu@tjh.tjmu.edu.cn
About this study
Official title: Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study
This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.
Read the detailed description
- To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
- Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
- To study the changes of Bispectral Index in the brain of patients treated with propofol during induction, maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults, and to compare with BIS（Bispectral Index） monitoring under propofol, and to study the characteristic changes of BIS（Bispectral Index） waveform in patients treated with propofol disodium.
- Conditions
- Drug Safety
- Being tested
- Fospropofol, Propofol
- Keywords
- Fospropofol, Efficacy and Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FospropofolDrug
Also called fospropofol disodium
Use fospropofol for general anesthesia maintenance
PropofolDrug
Also called Diprivan propofol
Use propofol for general anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol group | Experimental | patients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium. Receives: Drug: Fospropofol |
| Propofol group | Active comparator | patients in the propofol group received propofol, sufentanil, and rocuronium. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative hypotension
Incidence of hypotension throughout perioperative period
Measured: From the beginning to the end of surgery
Incidence of injection pain
Incidence of perceived injection pain during anesthesia induction
Measured: During induction of anesthesia
Secondary outcomes (4)
Glomerular filtration rate
The patients' glomerular filtration rate
Measured: First day after surgery
Eeg dual frequency exponential waveform
Eeg dual frequency index waveform during operation
Measured: From the beginning to the end of surgery
Urea nitrogen
Blood level of urea nitrogen
Measured: First day after surgery
Creatinine
Blood level of creatinine
Measured: First day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start15 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 373 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Xu, Tongji Hospital
- Investigators
- Tao Hong, Master, Study director, Tongji Hospital, Tongji Medical College, Huazhong University of Scien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573489
- Sponsor's protocol ID
- TJ-IRB202405048
- Status last verified
- Apr 2025
- First submitted
- 13 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dinis-Oliveira RJ. Metabolic Profiles of Propofol and Fospropofol: Clinical and Forensic Interpretative Aspects. Biomed Res Int. 2018 May 24;2018:6852857. doi: 10.1155/2018/6852857. eCollection 2018.
PubMed 29992157Patwardhan A, Edelmayer R, Annabi E, Price T, Malan P, Dussor G. Receptor specificity defines algogenic properties of propofol and fospropofol. Anesth Analg. 2012 Oct;115(4):837-40. doi: 10.1213/ANE.0b013e318258b9db. Epub 2012 May 14.
PubMed 22584560
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study
- ClinicalTrials.gov ID
- NCT06573489
- Acronym / sponsor ID
- TJ-IRB202405048
- Conditions
- Drug Safety
- Keywords
- Fospropofol, Efficacy and Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 373 participants (estimated)
- Lead sponsor
- Hui XuUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Aug 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 protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.
Detailed description
- To explore the lowest effective dose of fospropofol disodium for general anesthesia induction in adult laparoscopic abdominal surgery
- Observation on efficacy, safety and effective dose range of propofol disodium for general anesthesia maintenance in adult laparoscopic abdominal surgery
- To study the changes of Bispectral Index in the brain of patients treated with propofol during induction, maintenance and recovery of general anesthesia during laparoscopic abdominal surgery in adults, and to compare with BIS（Bispectral Index） monitoring under propofol, and to study the characteristic changes of BIS（Bispectral Index） waveform in patients treated with propofol disodium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol group | Experimental | Drug: Fospropofolpatients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium. |
| Propofol group | Active comparator | Drug: Propofolpatients in the propofol group received propofol, sufentanil, and rocuronium. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult age (18-65 years old)
- ASA（American Society of Anesthesiologists）grade I~II
- The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned
- BMI value 18-30kg /m2
- Voluntary signing of informed consent
Key exclusion criteria (11 listed)
- Those who have contraindications to general anesthesia or have a history of anesthesia accidents;
- Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;
- Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)
- uncontrolled diabetes or high blood pressure;
- A history of drug use, alcoholism or drug dependence;
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 |
|---|---|---|
| FospropofolAlso: fospropofol disodiumUse fospropofol for general anesthesia maintenance | Drug | Fospropofol group |
| PropofolAlso: Diprivan propofolUse propofol for general anesthesia maintenance | Drug | Propofol group |
Primary outcome
Incidence of perioperative hypotension
Time frame: From the beginning to the end of surgery
Incidence of hypotension throughout perioperative period
Incidence of injection pain
Time frame: During induction of anesthesia
Incidence of perceived injection pain during anesthesia induction
4 secondary outcomes
Glomerular filtration rate
Time frame: First day after surgery
Eeg dual frequency exponential waveform
Time frame: From the beginning to the end of surgery
Urea nitrogen
Time frame: First day after surgery
Creatinine
Time frame: First day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 29992157Dinis-Oliveira RJ. Metabolic Profiles of Propofol and Fospropofol: Clinical and Forensic Interpretative Aspects. Biomed Res Int. 2018 May 24;2018:6852857. doi: 10.1155/2018/6852857. eCollection 2018.
- Results publication: PubMed 22584560Patwardhan A, Edelmayer R, Annabi E, Price T, Malan P, Dussor G. Receptor specificity defines algogenic properties of propofol and fospropofol. Anesth Analg. 2012 Oct;115(4):837-40. doi: 10.1213/ANE.0b013e318258b9db. Epub 2012 May 14.
- 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.
Tao Hong, Master study director
Tongji Hospital, Tongji Medical College, Huazhong University of Scien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fospropofol and Propofol in people with Drug Safety, run by Hui Xu at 1 site 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Hong, Master (15927008056, whutthong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative hypotension (time frame: From the beginning to the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573489, which also lists 2 linked publications.
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 16 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.