Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia

Tongji Hospital

Status: Completed

Conditions: Adverse Effects; Remifentanil

Treatments: Drug: Sufentanil; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT07092384

ERPF

Details and patient eligibility

About

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

Full 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

Enrollment: 265 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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265 participants in 5 patient groups

Group R1

Experimental group

Description:

remifentanil 0.5μg/kg

Treatment:

Drug: Remifentanil

Group R2

Experimental group

Description:

remifentanil 1.0μg/kg

Treatment:

Drug: Remifentanil

Group R3

Experimental group

Description:

remifentanil 1.5μg/kg

Treatment:

Drug: Remifentanil

Group R4

Experimental group

Description:

remifentanil 2.0μg/kg

Treatment:

Drug: Remifentanil

Group S

Active Comparator group

Description:

sufentanil 0.3μg/kg

Treatment:

Drug: Sufentanil