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Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery

Inhibitory Effect of Different Doses of Propofol on Perineal Pruritus Caused by Dexamethasone Sodium Phosphate in Patients Undergoing Day Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05162430
Enrollment
150
Registered
2021-12-17
Start date
2021-01-20
Completion date
2021-12-04
Last updated
2021-12-17

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

Conditions

Pruritus Vulvae

Brief 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. 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.

Interventions

DRUGPropofol

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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Ramsay score10-30 secondsScoring of patients according to their mental status after administration of propofol.
Duration of pruritus3-6 minutesAfter the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end
Incidence of pruritus3-6 minutesCalculation of the occurrence of pruritus in each group.
Severity of pruritus3-6 minutesPruritus is classified as mild to moderate to severe according to the VAS score.
VAS score10-30 secondsPatients rate their pruritus according to the VAS scale.

Secondary

MeasureTime frameDescription
Adverse reactions3-6 minutesHypotension, respiratory depression, injection pain after propofol use, record it.

Countries

China

Outcome results

None listed

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