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The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

The Effect of Midazolam on Dexamethasone-induced Perineal Pruritus

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04326738
Enrollment
90
Registered
2020-03-30
Start date
2020-01-16
Completion date
2020-12-30
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus

Keywords

midazolam; Dexamethasone; pruritus

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.

Interventions

DRUGMidazolam

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)

DRUGnormal saline

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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Ramsay scoresin 3 minutes1 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 reactionsin 3 minutesdizziness and respiratory depression

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026