Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorShiyou Wei
About this 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.
Eligibility criteria
Qualifiers
Undergoing elective ureteroscopic surgery
Aged between 18 and 90 years old
American Society of Anesthesiologists (ASA) physical status classification grade I to III
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fospropofol disodium plus sufentanil for anesthesia induction
- Propofol plus sufentanil for anesthesia induction
Treatment groups
190 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Source ClinicalTrials.gov