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Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

NCT ID: NCT07092384

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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

Conditions

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Remifentanil Adverse Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group R1

remifentanil 0.5μg/kg

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Group R2

remifentanil 1.0μg/kg

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Group R3

remifentanil 1.5μg/kg

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Group R4

remifentanil 2.0μg/kg

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

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

Group S

sufentanil 0.3μg/kg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

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

Interventions

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Remifentanil

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Other Intervention Names

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remi sufen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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aihua Du, Dr.

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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ERPF

Identifier Type: -

Identifier Source: org_study_id