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

NCT05162430 | Completed

• 1 other identifier: wWang
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus Vulvae

Outcome Measures

Primary Outcomes (5)

• Duration of pruritus

  After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end

  3-6 minutes

• Incidence of pruritus

  Calculation of the occurrence of pruritus in each group.

  3-6 minutes

• Severity of pruritus

  Pruritus is classified as mild to moderate to severe according to the VAS score.

  3-6 minutes

• VAS score

  Patients rate their pruritus according to the VAS scale.

  10-30 seconds

• Ramsay score

  Scoring of patients according to their mental status after administration of propofol.

  10-30 seconds

Secondary Outcomes (1)

• Adverse reactions

  3-6 minutes

Study Arms (6)

P1 group

EXPERIMENTAL

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

Drug: Propofol

P2 group

EXPERIMENTAL

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

Drug: Propofol

P3 group

EXPERIMENTAL

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

Drug: Propofol

P4 group

EXPERIMENTAL

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

Drug: Propofol

P5 group

EXPERIMENTAL

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

Drug: Propofol

D1 group

NO INTERVENTION

Administration of 5mg dexamethasone phosphate sodium

Interventions

Propofol 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

P1 group; P2 group; P3 group; P4 group; P5 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Liu meiyu

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Pruritus Vulvae

Interventions

Propofol

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pruritus; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Liu m yu, Director

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 17, 2021
• Study Start: January 20, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 4, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

CN (1)