The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

NCT04326738 | Completed Early Phase 1

• 1 other identifier: 2020-YKL-003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 .

Conditions

Pruritus

Keywords

midazolam; Dexamethasone; pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ramsay scores

  in 3 minutes

• the occurrence of adverse reactions

  in 3 minutes

Study Arms (2)

normal saline (N) group

PLACEBO COMPARATOR

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

Drug: normal saline

midazolam (M) group

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Midazolam DRUG

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)

midazolam (M) group

normal saline DRUG

N group received corresponding intravenous normal saline of1ml·kg-1 .

normal saline (N) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated hospital of yangzhou university

Yangzhou, Jiangsu, 225100, China

Location

MeSH Terms

Conditions

Pruritus

Interventions

Midazolam; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• mei yu liu

  Yangzhou University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Hosptial of Yangzhou University

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: January 16, 2020
• Primary Completion: April 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

CN (1)