Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery

Yangzhou University

Status: Completed

Conditions: Pruritus Vulvae

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05162430

wWang

Details and patient eligibility

About

OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery.

METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4 and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). The perineal itching, the onset and duration of itching, the visual analogue score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence of adverse reactions were recorded in the five groups.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2

Exclusion criteria

Patients with paresthesia or pruritus Drug and alcohol abuse Allergies to lipid drugs and contraindications; corticosteroids are cautious Patients Hyperlipidemia Patients during pregnancy and lactation Mental diseases, communication disorders Patients who use hormones for a long time

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 6 patient groups

P1 group

Experimental group

Description:

Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium

Treatment:

Drug: Propofol

P2 group

Experimental group

Description:

Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium

Treatment:

Drug: Propofol

P3 group

Experimental group

Description:

Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium

Treatment:

Drug: Propofol

P4 group

Experimental group

Description:

Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium

Treatment:

Drug: Propofol

P5 group

Experimental group

Description:

Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium

Treatment:

Drug: Propofol

D1 group

No Intervention group

Description:

Administration of 5mg dexamethasone phosphate sodium