Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy

Официальное название

Fospropofol Disodium Versus Propofol on Patient Satisfaction in Patients Undergoing Ureteroscopy：A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

• 24-hour postoperative anesthesia satisfaction score (ISAS scale) [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (2)

• Incidence of injection pain [Срок оценки: Within 5 minutes from the beginning of intravenous anesthetic injection]
• Incidence of intraoperative cardiovascular adverse events [Срок оценки: During anesthesia induction and throughout the operation]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07659132 · 202620005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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