The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Pruritus Clinical Trial

Official title:

The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337073
• Other study ID #: MHong
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Elective female surgery patients, ages 18 to 65 years old, ASA ? or ? 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.

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Propofol
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.
• normal saline
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.

Locations

Country	Name	City	State
China	Affiliated hospital of yangzhou university	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in 3min
Secondary	the occurrence of adverse reactions	the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups	in 3min