An interventional study of Propofol in Pruritus Vulvae, sponsored by Yangzhou University. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Yangzhou University · Not applicable, Interventional, and Prevention
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.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
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Age 18-65 years old ASA classification I-II grade Body mass index (BMI) 18-30kg/m2
Exclusion Criteria:
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
Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium
Drug: Propofol
Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium
Drug: Propofol
Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium
Drug: Propofol
Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium
Drug: Propofol
Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium
Drug: Propofol
Administration of 5mg dexamethasone phosphate sodium
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
Duration of pruritus
After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end
Time frame: 3-6 minutes
Incidence of pruritus
Calculation of the occurrence of pruritus in each group.
Time frame: 3-6 minutes
Severity of pruritus
Pruritus is classified as mild to moderate to severe according to the VAS score.
Time frame: 3-6 minutes
VAS score
Patients rate their pruritus according to the VAS scale.
Time frame: 10-30 seconds
Ramsay score
Scoring of patients according to their mental status after administration of propofol.
Time frame: 10-30 seconds
Adverse reactions
Hypotension, respiratory depression, injection pain after propofol use, record it.
Time frame: 3-6 minutes
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Pruritus Vulvae
Yangzhou University