Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

Not Applicable

Recruiting

• Conditions: Remifentanil; Adverse Effects
• Interventions: Drug: Remifentanil; Drug: Sufentanil

• Registration Number: NCT07092384
• Lead Sponsor: Tongji Hospital

Brief Summary

Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults

Detailed Description

Explore the effect of remifentanil on pruritus and paresthesia caused by fospropofol disodium in adults, to observe the manifestations and duration of pruritus and paresthesia

Study Timeline

• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-22
• Study First Posted: 2025-07-29
• Study Start: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Age 18-80 years old, plans to undergo elective non-cardiac surgery under general anesthesia.
• ASA I-II;
• The operation duration > 30 min;
• BMI 18-30kg /m2；
• Sign the informed consent form.

Exclusion Criteria

• history of drug abuse or alcohol dependence;
• used sedative or analgesic drugs before operation;
• with severe liver and kidney function impairment;
• allergic to propofol and lipids;
• surgery that directly affect hemodynamics with surgical operations, such as macrovascular surgery;
• abnormal coagulation function, endocrine diseases or other effects on hemodynamic status;
• Participation in other clinical researchers in the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R1	Remifentanil	remifentanil 0.5μg/kg
Group R2	Remifentanil	remifentanil 1.0μg/kg
Group R3	Remifentanil	remifentanil 1.5μg/kg
Group R4	Remifentanil	remifentanil 2.0μg/kg
Group S	Sufentanil	sufentanil 0.3μg/kg

Primary Outcome Measures

Name	Time	Method
Incidence of pruritus and paresthesia after administration of fospropofol disodium	24 hours	Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration

Secondary Outcome Measures

Name	Time	Method
Time of pruritus or paresthesia	1 day	time of pruritus and paresthesia occur after administration and 24h after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 day	Incidence of Treatment-Emergent Adverse Events
dosage of drugs	1 day	Doses of drugs used during induction and maintenance of anesthesia
time records checklist	1 day	anesthesia time, induction time, surgical time, awakening time, and recovery time
duration of pruritus or paresthesia	24 hours	pruritus and paresthesia occur after administration and 24h after surgery

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China