The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Detailed Description
-----------------
Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. Dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.

Official Title
-----------------
The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

Conditions
-----------------
Adverse Effect

Intervention / Treatment
-----------------
* Drug: dezocine
* Other: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-65 years ASA physical status I-II BMI 18-24.5 kg/m2 Exclusion Criteria: On regular use of analgesic Contraindication or allergy to steroid or dezocine Drug or alcohol abuse Diagnosed with paresthesia or mental diseases Communication disorders Pregnancy or nursing

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>40 patients receive dezocine 0.1 mg/Kg | Drug: dezocine<br>* receive dezocine 0.1 mg/kg<br>|
| Placebo Comparator: Group C<br>40 patients receive matching placebo （normal saline） | Other: normal saline<br>* receive matching placebo (equal volume of normal saline)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo) |  | In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo) |  | In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dezocine, Dexamethasone 21-phosphate, Pain, Pruritus