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The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Primary Purpose

Pruritus

Status

Completed

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Propofol

normal saline

About this trial

This is an interventional prevention trial for Pruritus focused on measuring propofol; Dexamethasone; pruritus

Eligibility Criteria

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

Inclusion Criteria:

Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg/m2.

Exclusion Criteria:

diabetes mellitus, paresthesia, allergy to narcotic drugs, routine preoperative use of narcotic analgesics, long-term use of hormones, drug and alcohol abuse, communication disorders in psychiatric disorders, pregnancy or lactation, and patients with severe systemic diseases and unwilling to undergo the trial.

Sites / Locations

Affiliated hospital of yangzhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

normal saline (N) group

propofol (P) group

Arm Description

Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.

Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol

Outcomes

Primary Outcome Measures

visual analogue scale(VAS) scores

VAS score was used to grade the degree of perineal itching: VAS 0 was no discomfort, 1-3 was mild, 4-6 was moderate, and 7-10 was severe

Secondary Outcome Measures

the occurrence of adverse reactions

the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups

Full Information

NCT ID

NCT04337073

First Posted

April 3, 2020

Last Updated

February 8, 2022

Sponsor

Yangzhou University

1. Study Identification

Unique Protocol Identification Number

NCT04337073

Brief Title

The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Official Title

The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

October 1, 2020 (Actual)

Study Completion Date

November 30, 2020 (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

Data Monitoring Committee

5. Study Description

Brief Summary

patients may appear serious perineal itching, after injection of dexamethasone sodium phosphate injection its incidence is about 25% ~ 100%, and the incidence of the discomfort in females was much higher than that of the maleTo investigate the effect of propofol pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and explore the possible machanisms.

Detailed Description

40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI 18~30kg/m2 were selected in this study.The patients were equally randomized into two groups: propofol (P) group and normal saline (N) group, 20 cases in each group. Before anesthesia induction, M group received intravenous injection of 0.3mg/kg propofol , while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg. The anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups.

6. Conditions and Keywords

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

Pruritus

Keywords

propofol; Dexamethasone; pruritus

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

propofol (P) group and normal saline (N) group

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

normal saline (N) group

Arm Type

Placebo Comparator

Arm Description

Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.

Arm Title

propofol (P) group

Arm Type

Active Comparator

Arm Description

Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

Primary Outcome Measure Information:

Title

visual analogue scale(VAS) scores

Description

VAS score was used to grade the degree of perineal itching: VAS 0 was no discomfort, 1-3 was mild, 4-6 was moderate, and 7-10 was severe

Time Frame

in 3min

Secondary Outcome Measure Information:

Title

the occurrence of adverse reactions

Description

the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups

Time Frame

in 3min

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg/m2. Exclusion Criteria: diabetes mellitus, paresthesia, allergy to narcotic drugs, routine preoperative use of narcotic analgesics, long-term use of hormones, drug and alcohol abuse, communication disorders in psychiatric disorders, pregnancy or lactation, and patients with severe systemic diseases and unwilling to undergo the trial.

Facility Information:

Facility Name

Affiliated hospital of yangzhou university

City

Yangzhou

State/Province

Jiangsu

ZIP/Postal Code

225100

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

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