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The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

Primary Purpose

Pruritus

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Midazolam
normal saline
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pruritus focused on measuring midazolam; Dexamethasone; pruritus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

the undergoing elective surgery patients, ages 18 to 65 years, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg · m-2.

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.

Sites / Locations

  • Affiliated hospital of yangzhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

normal saline (N) group

midazolam (M) group

Arm Description

N group received corresponding intravenous normal saline of 1ml·kg-1.

M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam.

Outcomes

Primary Outcome Measures

itching measured by visual analogue scores
visual analogue scores(VAS)VAS 0 means no discomfort, 1-3 as mild, 4-6 as moderate, and 7-10 as severe

Secondary Outcome Measures

Ramsay scores
1 point, not quiet; 2 points, quiet cooperation; 3, drowsiness, ability to follow instructions; 4 points, sleep state, can wake up; 5 points, slow response; 6 points, deep sleep state
the occurrence of adverse reactions
dizziness and respiratory depression

Full Information

First Posted
March 26, 2020
Last Updated
February 8, 2022
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT04326738
Brief Title
The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus
Official Title
The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dexamethasone is commonly used in clinical practice.However, intravenous dexamethasone sodium phosphate may cause perineal discomfort.With the popularization of comfortable medical technology, patients have higher and higher requirements for comfortable medical treatment.Perineal pruritus caused by intravenous dexamethasone sodium phosphate may cause adverse physiological and psychological effects on patients and increase the incidence of unpleasant experiences during anesthesia.Therefore, it is very important to find a practical and effective method of inhibition.Midazolam is a water-soluble benzodiazepine commonly used in clinical practice, which has been proved to effectively inhibit the itching caused , while its effect on the itching caused by dexamethasone has not been reported.By observing the effect of pre-injection midazolam on the perineal itching caused by dexamethasone sodium phosphate, this experiment intends to preliminarily explore its possible mechanism .
Detailed Description
Nighty patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI 18~30kg·m-2 were selected in this study.The patients were equally randomized into two groups: midazolam (M) group and normal saline (N) group, 45 cases in each group. Before anesthesia induction, M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam, 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 (injection was completed in 2s). The anesthesiologist assessed perineal irritation in both groups and recorded the number of cases,visual analogue scores (VAS) ,duration of itching or pain,Ramsay scores and observed the occurrence of adverse reactions such as dizziness and respiratory depression in the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
midazolam; Dexamethasone; pruritus

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal saline (N) group
Arm Type
Placebo Comparator
Arm Description
N group received corresponding intravenous normal saline of 1ml·kg-1.
Arm Title
midazolam (M) group
Arm Type
Active Comparator
Arm Description
M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam, After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg (injection was completed in 2s)
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
N group received corresponding intravenous normal saline of1ml·kg-1 .
Primary Outcome Measure Information:
Title
itching measured by visual analogue scores
Description
visual analogue scores(VAS)VAS 0 means no discomfort, 1-3 as mild, 4-6 as moderate, and 7-10 as severe
Time Frame
in 3 minutes
Secondary Outcome Measure Information:
Title
Ramsay scores
Description
1 point, not quiet; 2 points, quiet cooperation; 3, drowsiness, ability to follow instructions; 4 points, sleep state, can wake up; 5 points, slow response; 6 points, deep sleep state
Time Frame
in 3 minutes
Title
the occurrence of adverse reactions
Description
dizziness and respiratory depression
Time Frame
in 3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the undergoing elective surgery patients, ages 18 to 65 years, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg · m-2. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mei yu liu
Organizational Affiliation
Yangzhou University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated hospital of yangzhou university
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225100
Country
China

12. IPD Sharing Statement

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The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

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