The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT04326738

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Drug: Midazolam Drug: normal saline	Early Phase 1

Detailed Description

Nighty patients scheduled for selective surgery,aged 18-65years,ASA physical status I_II,BMI
1830kg·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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

Actual Study Start Date :

Jan 16, 2020

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

itching measured by visual analogue scores [in 3 minutes]
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 [in 3 minutes]
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 [in 3 minutes]
dizziness and respiratory depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated hospital of yangzhou university	Yangzhou	Jiangsu	China	225100

Sponsors and Collaborators

Yangzhou University

Investigators

Study Director: mei yu liu, Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ma Hong, Affiliated Hosptial of Yangzhou University, Yangzhou University

ClinicalTrials.gov Identifier:

NCT04326738

Other Study ID Numbers:

2020-YKL-003

First Posted:

Mar 30, 2020

Last Update Posted:

Feb 10, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ma Hong, Affiliated Hosptial of Yangzhou University, Yangzhou University

midazolam; Dexamethasone; pruritus

Additional relevant MeSH terms:

Pruritus

Midazolam

Study Results

No Results Posted as of Feb 10, 2022