- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337073
The Effect of Propofol on Dexamethasone-induced Perineal Pruritus
February 8, 2022 updated by: Ma Hong, Yangzhou University
patients may appear serious perineal itching, after injection of dexamethasone sodium phosphate injection its incidence is about 25% ~ 100%, and the incidence of the discomfort in females was much higher than that of the maleTo investigate the effect of propofol pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and explore the possible machanisms.
Study Overview
Detailed Description
40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI 18~30kg/m2 were selected in this study.The patients were equally randomized into two groups: propofol (P) group and normal saline (N) group, 20 cases in each group.
Before anesthesia induction, M group received intravenous injection of 0.3mg/kg propofol , 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.
The anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225100
- Affiliated Hospital of Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 ~ 30 kg/m2.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: normal saline (N) group
Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.
|
Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, 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.
|
Active Comparator: propofol (P) group
Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol
|
Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analogue scale(VAS) scores
Time Frame: in 3min
|
VAS score was used to grade the degree of perineal itching: VAS 0 was no discomfort, 1-3 was mild, 4-6 was moderate, and 7-10 was severe
|
in 3min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the occurrence of adverse reactions
Time Frame: in 3min
|
the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups
|
in 3min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
April 3, 2020
First Submitted That Met QC Criteria
April 3, 2020
First Posted (Actual)
April 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 25, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHong
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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