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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Fospropofol disodium plus sufentanil for anesthesia induction
DrugIntravenous 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 induction
DrugIntravenous 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
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Fospropofol Disodium Induction GroupExperimental treatment 1 intervention
Group B: Propofol Induction GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
24 hours after surgerySecondary outcomes
1
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 injection2
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 operationOther outcomes
1
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 postoperatively2
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 injection3
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 injection4
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 injectionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Source ClinicalTrials.gov
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