NCT04337073

The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Yangzhou University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pruritus

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-10-01
• Completion: 2020-11-30
• First posted: 2020-04-07
• Last updated: 2022-02-25

Locations

1 site across 1 country: China