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

Not Applicable

Completed

• Conditions: Pruritus Vulvae
• Interventions: Drug: Propofol

• Registration Number: NCT05162430
• Lead Sponsor: Yangzhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Status Verified: 2021-12
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-04
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-04
• Last Update Submitted: 2021-12-04
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P1 group	Propofol	Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium
P2 group	Propofol	Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium
P3 group	Propofol	Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium
P5 group	Propofol	Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium
P4 group	Propofol	Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium

Primary Outcome Measures

Name	Time	Method
Duration of pruritus	3-6 minutes	After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end
Incidence of pruritus	3-6 minutes	Calculation of the occurrence of pruritus in each group.
Severity of pruritus	3-6 minutes	Pruritus is classified as mild to moderate to severe according to the VAS score.
VAS score	10-30 seconds	Patients rate their pruritus according to the VAS scale.
Ramsay score	10-30 seconds	Scoring of patients according to their mental status after administration of propofol.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	3-6 minutes	Hypotension, respiratory depression, injection pain after propofol use, record it.

Trial Locations

Locations (1)

Liu meiyu; 🇨🇳 Yangzhou, Jiangsu, China