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临床试验/NCT07659132
NCT07659132尚未招募4 期

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

Shiyou Wei0 个研究点目标入组 190 人开始时间: 2026年6月26日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
190

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Fospropofol disodium plus sufentanil for anesthesia induction (Drug)

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.

干预措施: Propofol plus sufentanil for anesthesia induction (Drug)

研究者

发起方
Shiyou Wei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shiyou Wei

Attending Anesthesiologist

Shanghai Pulmonary Hospital, Shanghai, China

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