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

Primary Purpose

Pruritus Vulvae

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Propofol

About this trial

This is an interventional prevention trial for Pruritus Vulvae

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Liu meiyu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Arm Label

P1 group

P2 group

P3 group

P4 group

P5 group

D1 group

Arm Description

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

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

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

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

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

Administration of 5mg dexamethasone phosphate sodium

Outcomes

Primary Outcome Measures

Duration of pruritus

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

Incidence of pruritus

Calculation of the occurrence of pruritus in each group.

Severity of pruritus

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

VAS score

Patients rate their pruritus according to the VAS scale.

Ramsay score

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

Secondary Outcome Measures

Adverse reactions

Hypotension, respiratory depression, injection pain after propofol use, record it.

Full Information

NCT ID

NCT05162430

First Posted

December 4, 2021

Last Updated

December 4, 2021

Sponsor

Yangzhou University

1. Study Identification

Unique Protocol Identification Number

NCT05162430

Brief Title

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

Official Title

Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

January 20, 2021 (Actual)

Primary Completion Date

December 3, 2021 (Actual)

Study Completion Date

December 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus Vulvae

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P1 group

Arm Type

Experimental

Arm Description

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

Arm Title

P2 group

Arm Type

Experimental

Arm Description

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

Arm Title

P3 group

Arm Type

Experimental

Arm Description

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

Arm Title

P4 group

Arm Type

Experimental

Arm Description

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

Arm Title

P5 group

Arm Type

Experimental

Arm Description

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

Arm Title

D1 group

Arm Type

No Intervention

Arm Description

Administration of 5mg dexamethasone phosphate sodium

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of pruritus

Description

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

Time Frame

3-6 minutes

Title

Incidence of pruritus

Description

Calculation of the occurrence of pruritus in each group.

Time Frame

3-6 minutes

Title

Severity of pruritus

Description

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

Time Frame

3-6 minutes

Title

VAS score

Description

Patients rate their pruritus according to the VAS scale.

Time Frame

10-30 seconds

Title

Ramsay score

Description

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

Time Frame

10-30 seconds

Secondary Outcome Measure Information:

Title

Adverse reactions

Description

Hypotension, respiratory depression, injection pain after propofol use, record it.

Time Frame

3-6 minutes

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liu m yu, Director

Organizational Affiliation

Yangzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liu meiyu

City

Yangzhou

State/Province

Jiangsu

ZIP/Postal Code

225000

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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