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NCT Number: NCT07092384

Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

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

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Key information

Conditions

Remifentanil Adverse Effects

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Other names: remi

Sufentanil

Drug

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

Other names: sufen

Primary outcomes

  1. Incidence of pruritus and paresthesia after administration of fospropofol disodium

    Time frame: 24 hours

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

Secondary outcomes

  1. Time of pruritus or paresthesia

    Time frame: 1 day

    time of pruritus and paresthesia occur after administration and 24h after surgery

  2. dosage of drugs

    Time frame: 1 day

    Doses of drugs used during induction and maintenance of anesthesia

  3. time records checklist

    Time frame: 1 day

    anesthesia time, induction time, surgical time, awakening time, and recovery time

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

    Time frame: 1 day

    Incidence of Treatment-Emergent Adverse Events

  5. duration of pruritus or paresthesia

    Time frame: 24 hours

    pruritus and paresthesia occur after administration and 24h after surgery

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Effect of Remifentanil on Pruritus and Paresthesia Caused by Fospropofol Disodium Anesthesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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