Anesthesia for Urologic Endoscopic SurgeryPhase 4NCT07659132
Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy
A Phase 4 study testing Fospropofol disodium plus sufentanil for anesthesia induction and Propofol plus sufentanil for anesthesia induction in people with Anesthesia for Urologic Endoscopic Surgery and Urinary Calculi, run by Shiyou Wei.
Trial summary
This single-center single-blind randomized trial compares fospropofol disodium and propofol for anesthesia in elective ureteroscopy patients. A total of 190 eligible adults will be randomly divided into two groups at 1:1 ratio with identical intraoperative maintenance protocols. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia for Urologic Endoscopic Surgery, Urinary Calculi
- What is being tested?
- Fospropofol disodium plus sufentanil for anesthesia induction and Propofol plus sufentanil for anesthesia induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2026to 26 Sep 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective ureteroscopic surgery
- Aged between 18 and 90 years old
- American Society of Anesthesiologists (ASA) physical status classification grade I to III
Who cannot join
- Known allergy to propofol, fospropofol or their excipients
- Severe cardiopulmonary insufficiency
- Hepatic and renal dysfunction.Hepatic or renal insufficiency. Hepatic dysfunction: alanine aminotransferase (ALT) > 50 U/L, or aspartate aminotransferase (AST) > 40 U/L, or total bilirubin (TBIL) ≥ 19 μmol/L; Renal dysfunction: serum creatinine (Cr) > 112 μmol/L, or blood urea nitrogen (BUN) > 7.1 mmol/L, or receiving dialysis within 28 days before surgery.
- Pregnancy, lactation, potential pregnancy or planned pregnancy
- Subjects who refuse to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fospropofol Disodium Versus Propofol on Patient Satisfaction in Patients Undergoing Ureteroscopy：A Randomized Controlled Trial
This single-center single-blind randomized trial compares fospropofol disodium and propofol for anesthesia in elective ureteroscopy patients. A total of 190 eligible adults will be randomly divided into two groups at 1:1 ratio with identical intraoperative maintenance protocols. The primary outcome is 24-hour postoperative anesthesia satisfaction assessed by ISAS scale; secondary and safety endpoints include injection pain, intraoperative hemodynamic events and various perioperative adverse reactions. This study explores the clinical efficacy and safety of the two sedatives to guide rational clinical medication.
Read the detailed description
This prospective parallel-group randomized controlled trial will recruit 190 ASA I-III adult patients aged 18-80 undergoing elective ureteroscopic lithotripsy. Participants will be randomly allocated to the fospropofol disodium group or conventional propofol group in a 1:1 ratio via computer-generated random sequence. Only subjects are blinded to the assigned induction sedative, while anesthesiologists and outcome evaluators remain unblinded to ensure accurate intraoperative management and objective indicator assessment.
All patients receive standardized sufentanil pretreatment before sedative injection, followed by uniform intraoperative anesthesia maintenance, muscle relaxant and postoperative antiemetic regimens to eliminate confounding variables between groups. The primary evaluation index, Iowa Satisfaction with Anesthesia Scale (ISAS) total score, will be collected 24 hours after surgery to reflect overall patient experience of anesthesia. Multiple secondary indicators will be observed throughout the perioperative period: injection pain during drug administration, sedation success rate within 5 minutes after induction, intraoperative hypertension/hypotension/tachycardia/bradycardia, incidence of pruritus, postoperative nausea and vomiting at 6 and 24 hours, plus all other unlisted anesthesia-related adverse events recorded from induction to 24-hour postoperative follow-up.
The whole research plan, informed consent form and assessment scales have obtained formal approval from the Medical Ethics Committee of Tianmen First People's Hospital (Tianmen Hospital Affiliated to Wuhan University of Science and Technology). Every eligible patient will receive full trial explanation and sign written informed consent before enrollment. All clinical data will be recorded on standardized paper CRFs and double-checked by two trained researchers to guarantee data integrity and authenticity. No electronic data capture (EDC) system is adopted in this trial. The final comparative analysis of efficacy and safety outcomes will be performed after full completion of participant recruitment and follow-up.
- Being tested
- Fospropofol disodium plus sufentanil for anesthesia induction, Propofol plus sufentanil for anesthesia induction
- Keywords
- fospropofol disodium, propofol, ureteroscopy, anesthesia satisfaction, sedation
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol disodium plus sufentanil for anesthesia inductionDrug
Intravenous injection of fospropofol disodium combined with sufentanil for anesthesia induction before ureteroscopic surgery. Intraoperative anesthetic maintenance, muscle relaxants and postoperative supportive treatment are consistent with the propofol control group to eliminate intergroup confounding factors.
Propofol plus sufentanil for anesthesia inductionDrug
Intravenous injection of conventional propofol combined with sufentanil for anesthesia induction before ureteroscopic surgery. All intraoperative and postoperative auxiliary treatment regimens are identical to the fospropofol disodium experimental group
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol Disodium Induction Group | Experimental | Intravenous anesthesia induction using fospropofol disodium combined with sufentanil. Intraoperative anesthetic maintenance, muscle relaxants and postoperative supportive management are identical to the control group Receives: Drug: Fospropofol disodium plus sufentanil for anesthesia induction |
| Propofol Induction Group | Active comparator | Intravenous anesthesia induction using standard propofol combined with sufentanil. All intraoperative and postoperative auxiliary treatment regimens are consistent with the experimental group to avoid confounding variables. Receives: Drug: Propofol plus sufentanil for anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour postoperative anesthesia satisfaction score (ISAS scale)
Total score of Iowa Satisfaction with Anesthesia Scale (ISAS) completed by subjects at 24 hours after ureteroscopic surgery, used to evaluate overall patient experience and satisfaction with anesthesia induction.
Measured: 24 hours after surgery
Secondary outcomes (2)
Incidence of injection pain
The proportion of participants who report venous injection pain during intravenous administration of anesthetic induction drugs, assessed within 5 minutes of injection start.
Measured: Within 5 minutes from the beginning of intravenous anesthetic injection
Incidence of intraoperative cardiovascular adverse events
Proportion of subjects experiencing intraoperative cardiovascular adverse reactions including hypotension, hypertension, bradycardia and tachycardia from anesthesia induction to the end of surgery.
Measured: During anesthesia induction and throughout the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia for Urologic Endoscopic SurgeryStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659132
- Sponsor's protocol ID
- 202620005
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fospropofol Disodium Versus Propofol on Patient Satisfaction in Patients Undergoing Ureteroscopy：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07659132
- Acronym / sponsor ID
- 202620005
- Keywords
- fospropofol disodium, propofol, ureteroscopy, anesthesia satisfaction, sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (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 single-center single-blind randomized trial compares fospropofol disodium and propofol for anesthesia in elective ureteroscopy patients. A total of 190 eligible adults will be randomly divided into two groups at 1:1 ratio with identical intraoperative maintenance protocols. The primary outcome is 24-hour postoperative anesthesia satisfaction assessed by ISAS scale; secondary and safety endpoints include injection pain, intraoperative hemodynamic events and various perioperative adverse reactions. This study explores the clinical efficacy and safety of the two sedatives to guide rational clinical medication.
Detailed description
This prospective parallel-group randomized controlled trial will recruit 190 ASA I-III adult patients aged 18-80 undergoing elective ureteroscopic lithotripsy. Participants will be randomly allocated to the fospropofol disodium group or conventional propofol group in a 1:1 ratio via computer-generated random sequence. Only subjects are blinded to the assigned induction sedative, while anesthesiologists and outcome evaluators remain unblinded to ensure accurate intraoperative management and objective indicator assessment.
All patients receive standardized sufentanil pretreatment before sedative injection, followed by uniform intraoperative anesthesia maintenance, muscle relaxant and postoperative antiemetic regimens to eliminate confounding variables between groups. The primary evaluation index, Iowa Satisfaction with Anesthesia Scale (ISAS) total score, will be collected 24 hours after surgery to reflect overall patient experience of anesthesia. Multiple secondary indicators will be observed throughout the perioperative period: injection pain during drug administration, sedation success rate within 5 minutes after induction, intraoperative hypertension/hypotension/tachycardia/bradycardia, incidence of pruritus, postoperative nausea and vomiting at 6 and 24 hours, plus all other unlisted anesthesia-related adverse events recorded from induction to 24-hour postoperative follow-up.
The whole research plan, informed consent form and assessment scales have obtained formal approval from the Medical Ethics Committee of Tianmen First People's Hospital (Tianmen Hospital Affiliated to Wuhan University of Science and Technology). Every eligible patient will receive full trial explanation and sign written informed consent before enrollment. All clinical data will be recorded on standardized paper CRFs and double-checked by two trained researchers to guarantee data integrity and authenticity. No electronic data capture (EDC) system is adopted in this trial. The final comparative analysis of efficacy and safety outcomes will be performed after full completion of participant recruitment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol Disodium Induction Group | Experimental | Drug: Fospropofol disodium plus sufentanil for anesthesia inductionIntravenous anesthesia induction using fospropofol disodium combined with sufentanil. Intraoperative anesthetic maintenance, muscle relaxants and postoperative supportive management are identical to the control group |
| Propofol Induction Group | Active comparator | Drug: Propofol plus sufentanil for anesthesia inductionIntravenous anesthesia induction using standard propofol combined with sufentanil. All intraoperative and postoperative auxiliary treatment regimens are consistent with the experimental group to avoid confounding variables. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective ureteroscopic surgery
- Aged between 18 and 90 years old
- American Society of Anesthesiologists (ASA) physical status classification grade I to III
Key exclusion criteria (5 listed)
- Known allergy to propofol, fospropofol or their excipients
- Severe cardiopulmonary insufficiency
- Hepatic and renal dysfunction.Hepatic or renal insufficiency. Hepatic dysfunction: alanine aminotransferase (ALT) > 50 U/L, or aspartate aminotransferase (AST) > 40 U/L, or total bilirubin (TBIL) ≥ 19 μmol/L; Renal dysfunction: serum creatinine (Cr) > 112 μmol/L, or blood urea nitrogen (BUN) > 7.1 mmol/L, or receiving dialysis within 28 days before surgery.
- Pregnancy, lactation, potential pregnancy or planned pregnancy
- Subjects who refuse to participate
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 plus sufentanil for anesthesia inductionIntravenous injection of fospropofol disodium combined with sufentanil for anesthesia induction before ureteroscopic surgery. Intraoperative anesthetic maintenance, muscle relaxants and postoperative supportive treatment are consistent with the propofol control group to eliminate intergroup confounding factors. | Drug | Fospropofol Disodium Induction Group |
| Propofol plus sufentanil for anesthesia inductionIntravenous injection of conventional propofol combined with sufentanil for anesthesia induction before ureteroscopic surgery. All intraoperative and postoperative auxiliary treatment regimens are identical to the fospropofol disodium experimental group | Drug | Propofol Induction Group |
Primary outcome
24-hour postoperative anesthesia satisfaction score (ISAS scale)
Time frame: 24 hours after surgery
Total score of Iowa Satisfaction with Anesthesia Scale (ISAS) completed by subjects at 24 hours after ureteroscopic surgery, used to evaluate overall patient experience and satisfaction with anesthesia induction.
2 secondary outcomes
Incidence of injection pain
Time frame: Within 5 minutes from the beginning of intravenous anesthetic injection
Incidence of intraoperative cardiovascular adverse events
Time frame: During anesthesia induction and throughout the operation
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 24 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fospropofol disodium plus sufentanil for anesthesia induction and Propofol plus sufentanil for anesthesia induction in people with Anesthesia for Urologic Endoscopic Surgery and Urinary Calculi, run by Shiyou Wei.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shiyou W Wei (+86 15601680288, lovewishyou@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour postoperative anesthesia satisfaction score (ISAS scale) (time frame: 24 hours after surgery). 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 24 Jun 2026.