The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJuly 6, 2021
June 1, 2021
2 months
October 23, 2020
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of dexamethasone-induced perineal irritation
The investigators record the number of cases of dexamethasone-induced perineal irritation (pain or pruritus) and calculate the incidence
During the first 3 min period after the injection of dexamethasone
Secondary Outcomes (2)
Duration of perineal irritation
After the injection of dexamethasone, up to 5 minutes
The severity of perineal irritation
After the injection of dexamethasone, up to 5 minutes
Study Arms (4)
2 ml dexamethasone (5 mg/ml)
ACTIVE COMPARATOR50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s.
5 ml dexamethasone (2mg/ml)
EXPERIMENTAL50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
10 ml dexamethasone (1mg/ml)
EXPERIMENTAL50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
20 ml dexamethasone (0.5mg/ml)
EXPERIMENTAL50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
Interventions
receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose
receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose
receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose
Eligibility Criteria
You may qualify if:
- Aged 18-65 years
- ASA physical status I-II
You may not qualify if:
- On regular use of analgesic
- Contraindication or allergy to steroid or glucose
- Drug or alcohol abuse
- Diagnosed with paresthesia or mental diseases
- Communication disorders
- Pregnancy or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yonghai Zhang
General Hospital of Ningxia Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2020
First Posted
July 6, 2021
Study Start
July 15, 2021
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
July 6, 2021
Record last verified: 2021-06