Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

NCT07092384 | Completed DMC

• 1 other identifier: ERPF
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adverse Effects; Remifentanil

Outcome Measures

Primary Outcomes (1)

• Incidence of pruritus and paresthesia after administration of fospropofol disodium

  Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration

  24 hours

Secondary Outcomes (5)

• Time of pruritus or paresthesia

  1 day

• dosage of drugs

  1 day

• time records checklist

  1 day

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 day

• duration of pruritus or paresthesia

  24 hours

Study Arms (5)

Group R1

EXPERIMENTAL

remifentanil 0.5μg/kg

Drug: Remifentanil

Group R2

EXPERIMENTAL

remifentanil 1.0μg/kg

Drug: Remifentanil

Group R3

EXPERIMENTAL

remifentanil 1.5μg/kg

Drug: Remifentanil

Group R4

EXPERIMENTAL

remifentanil 2.0μg/kg

Drug: Remifentanil

Group S

ACTIVE COMPARATOR

sufentanil 0.3μg/kg

Drug: Sufentanil

Interventions

Remifentanil DRUG

Observe the incidence of pruritus and paresthesia after different doses of remifentanil and fospropofol disodium

Also known as: remi

Group R1; Group R2; Group R3; Group R4

Sufentanil DRUG

Observe the incidence of pruritus and paresthesia after sufentanil and fospropofol disodium

Also known as: sufen

Group S

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Remifentanil; Sufentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl

Study Officials

• aihua Du, Dr.

  Tongji Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 29, 2025
• Study Start: July 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)