The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

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 .

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: normal saline; Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225100
      • Affiliated Hospital of Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline (N) group; N group received corresponding intravenous normal saline of 1ml·kg-1.	Drug: normal saline; N group received corresponding intravenous normal saline of1ml·kg-1 .
Active Comparator: midazolam (M) group; M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam.	Drug: Midazolam; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	in 3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	in 3 minutes
the occurrence of adverse reactions	dizziness and respiratory depression	in 3 minutes

Collaborators and Investigators

• Sponsor: Yangzhou University
• Investigators: Study Director: mei yu liu, Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: midazolam; Dexamethasone; pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 2020-YKL-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No