A Phase 4 interventional study of Fospropofol disodium plus sufentanil for anesthesia induction and Propofol plus sufentanil for anesthesia induction in Anesthesia for Urologic Endoscopic Surgery and Urinary Calculi, sponsored by Shiyou Wei. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Shiyou Wei · Phase 4, Interventional, and Treatment
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.
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 190 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Shiyou Wei is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous anesthesia induction using fospropofol disodium combined with sufentanil. Intraoperative anesthetic maintenance, muscle relaxants and postoperative supportive management are identical to the control group
Drug: Fospropofol disodium plus sufentanil for anesthesia induction
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.
Drug: Propofol plus sufentanil for anesthesia induction
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.
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
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.
Time frame: 24 hours after surgery
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.
Time frame: 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.
Time frame: During anesthesia induction and throughout the operation
Incidence of postoperative nausea and vomiting
The proportion of participants who experience nausea or vomiting assessed at 6 hours and 24 hours after ureteroscopic surgery.
Time frame: At 6 hours and 24 hours postoperatively
Incidence of paresthesia
The percentage of subjects who report abnormal skin paresthesia during intravenous injection of anesthetic induction drugs, evaluated within 5 minutes after injection initiation.
Time frame: Within 5 minutes from the beginning of intravenous anesthetic injection
Incidence of pruritus
The proportion of participants with pruritus during intravenous injection of anesthetic induction drugs, assessed within 5 minutes after the start of injection.
Time frame: Within 5 minutes from the beginning of intravenous anesthetic injection
Sedation success rate
The proportion of subjects who reach satisfactory sedation depth suitable for ureteroscopic surgery, assessed 5 minutes after intravenous injection of anesthetic induction drugs.
Time frame: 5 minutes after intravenous anesthetic injection
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Plan to share: No
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Shiyou Wei