The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Conditions
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Pruritus

Intervention / Treatment
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* Drug: Propofol
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: propofol (P) group and normal saline (N) group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline (N) group<br>Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume. | Drug: normal saline<br>* 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.<br>|
| Active Comparator: propofol (P) group<br>Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol | Drug: Propofol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of adverse reactions | the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups | in 3min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol; Dexamethasone; pruritus