Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy

NCT07659132 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 202620005
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Anesthesia for Urologic Endoscopic Surgery; Urinary Calculi

Keywords

fospropofol disodium; propofol; ureteroscopy; anesthesia satisfaction; sedation

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after surgery

Secondary Outcomes (2)

• Incidence of injection pain

  Within 5 minutes from the beginning of intravenous anesthetic injection

• Incidence of intraoperative cardiovascular adverse events

  During anesthesia induction and throughout the operation

Other Outcomes (4)

• Incidence of postoperative nausea and vomiting

  At 6 hours and 24 hours postoperatively

• Incidence of paresthesia

  Within 5 minutes from the beginning of intravenous anesthetic injection

• Incidence of pruritus

  Within 5 minutes from the beginning of intravenous anesthetic injection

Study Arms (2)

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

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.

Drug: Propofol plus sufentanil for anesthesia induction

Interventions

Fospropofol disodium plus sufentanil for anesthesia induction DRUG

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.

Fospropofol Disodium Induction Group

Propofol plus sufentanil for anesthesia induction DRUG

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

Propofol Induction Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective ureteroscopic surgery
• Aged between 18 and 90 years old
• American Society of Anesthesiologists (ASA) physical status classification grade I to III

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiyou Wei: lead

MeSH Terms

Conditions

Urinary Calculi

Interventions

fospropofol; Sufentanil; Propofol

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Shiyou W Wei

CONTACT

+86 15601680288; lovewishyou@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share