Pruritus VulvaeNCT05162430
Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery
A study testing Propofol in people with Pruritus Vulvae, run by Yangzhou University at 1 site in China.
Trial summary
OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pruritus Vulvae
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 4 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2
Who cannot join
- Patients with paresthesia or pruritus Drug and alcohol abuse Allergies to lipid drugs and contraindications; corticosteroids are cautious Patients Hyperlipidemia Patients during pregnancy and lactation Mental diseases, communication disorders Patients who use hormones for a long time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery
OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery.
METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4 and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). The perineal itching, the onset and duration of itching, the visual analogue score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence of adverse reactions were recorded in the five groups.
- Conditions
- Pruritus Vulvae
- Being tested
- Propofol
- Medical subject headings
- Pruritus Vulvae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
| Study group | Role | What they receive |
|---|---|---|
| P1 group | Experimental | Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium Receives: Drug: Propofol |
| P2 group | Experimental | Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium Receives: Drug: Propofol |
| P3 group | Experimental | Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium Receives: Drug: Propofol |
| P4 group | Experimental | Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium Receives: Drug: Propofol |
| P5 group | Experimental | Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium Receives: Drug: Propofol |
| D1 group | No intervention | Administration of 5mg dexamethasone phosphate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pruritus
After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end
Measured: 3-6 minutes
Incidence of pruritus
Calculation of the occurrence of pruritus in each group.
Measured: 3-6 minutes
Severity of pruritus
Pruritus is classified as mild to moderate to severe according to the VAS score.
Measured: 3-6 minutes
VAS score
Patients rate their pruritus according to the VAS scale.
Measured: 10-30 seconds
Ramsay score
Scoring of patients according to their mental status after administration of propofol.
Measured: 10-30 seconds
Secondary outcomes (1)
Adverse reactions
Hypotension, respiratory depression, injection pain after propofol use, record it.
Measured: 3-6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start20 Jan 2021
- Primary completion3 Dec 2021
- Study completion4 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus VulvaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang wanxia, Yangzhou University
- Investigators
- Liu m yu, Director, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162430
- Sponsor's protocol ID
- wWang
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery
- ClinicalTrials.gov ID
- NCT05162430
- Acronym / sponsor ID
- wWang
- Conditions
- Pruritus Vulvae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 4 Dec 2021 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal pruritus induced by dexamethasone sodium phosphate injection in women, with a view to providing clinical reference for comfortable clinical care in day surgery.
METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4 and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all five groups). The perineal itching, the onset and duration of itching, the visual analogue score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence of adverse reactions were recorded in the five groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| P1 group | Experimental | Drug: PropofolAdministration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium |
| P2 group | Experimental | Drug: PropofolAdministration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium |
| P3 group | Experimental | Drug: PropofolAdministration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium |
| P4 group | Experimental | Drug: PropofolAdministration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium |
| P5 group | Experimental | Drug: PropofolAdministration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium |
| D1 group | No intervention | –Administration of 5mg dexamethasone phosphate sodium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2
Key exclusion criteria (1 listed)
- Patients with paresthesia or pruritus Drug and alcohol abuse Allergies to lipid drugs and contraindications; corticosteroids are cautious Patients Hyperlipidemia Patients during pregnancy and lactation Mental diseases, communication disorders Patients who use hormones for a long time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s | Drug | P1 group, P2 group, P3 group, P4 group, P5 group |
Primary outcome
Duration of pruritus
Time frame: 3-6 minutes
After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end
Incidence of pruritus
Time frame: 3-6 minutes
Calculation of the occurrence of pruritus in each group.
Severity of pruritus
Time frame: 3-6 minutes
Pruritus is classified as mild to moderate to severe according to the VAS score.
VAS score
Time frame: 10-30 seconds
Patients rate their pruritus according to the VAS scale.
Ramsay score
Time frame: 10-30 seconds
Scoring of patients according to their mental status after administration of propofol.
1 secondary outcome
Adverse reactions
Time frame: 3-6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu m yu, Director principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Pruritus Vulvae, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of pruritus (time frame: 3-6 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.