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

NCT ID: NCT05162430

Last Updated: 2021-12-17

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-12-04

Brief Summary

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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

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Conditions

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Pruritus Vulvae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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P1 group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

P2 group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

P3 group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

P4 group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

P5 group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

D1 group

Administration of 5mg dexamethasone phosphate sodium

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Propofol

0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Wang wanxia

student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu m yu, Director

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

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Liu meiyu

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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wWang

Identifier Type: -

Identifier Source: org_study_id