Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Calculi; Anesthesia for Urologic Endoscopic Surgery
• Intervention / Treatment: Drug: Fospropofol disodium plus sufentanil for anesthesia induction; Drug: Propofol plus sufentanil for anesthesia induction

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 Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shiyou W Wei; Phone Number: +86 15601680288; Email: lovewishyou@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1: Patients undergoing elective ureteroscopic surgery 2: Aged between 18 and 90 years old 3: American Society of Anesthesiologists (ASA) physical status classification grade I to III

Exclusion Criteria:

- 1: Known allergy to propofol, fospropofol or their excipients 2: Severe cardiopulmonary insufficiency 3: 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.

4: Pregnancy, lactation, potential pregnancy or planned pregnancy 5: Subjects who refuse to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fospropofol Disodium Induction Group; 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 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.
Active Comparator: Propofol Induction Group; 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During anesthesia induction and throughout the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	5 minutes after intravenous anesthetic injection

Collaborators and Investigators

• Sponsor: Shiyou Wei

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 26, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sedation; propofol; ureteroscopy; fospropofol disodium; anesthesia satisfaction
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Pathological Conditions, Signs and Symptoms; Urinary Calculi; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Fentanyl; Propofol; Sufentanil; fospropofol
• Other Study ID Numbers: 202620005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No