The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation

August 2, 2016 updated by: General Hospital of Ningxia Medical University
The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Other Outcome Measures

Outcome Measure
Time Frame
The duration 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)
Time Frame: In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate
In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Principal Investigator: Junwei Zheng, General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mz2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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