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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol disodium plus sufentanil for anesthesia induction | Drug | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyou W Wei | Contact | +86 15601680288 | lovewishyou@tongji.edu.cn |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
| D017409 | Sufentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Propofol plus sufentanil for anesthesia induction | Drug | 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 |
|
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 |
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |