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Completed

NCT Number: NCT05162430

Inhibitory Effect of Propofol on Perineal Pruritus 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Liu meiyu

Yangzhou, Jiangsu, 225000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Primary outcomes

  1. Duration of pruritus

    Time frame: 3-6 minutes

    After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end

  2. Incidence of pruritus

    Time frame: 3-6 minutes

    Calculation of the occurrence of pruritus in each group.

  3. Severity of pruritus

    Time frame: 3-6 minutes

    Pruritus is classified as mild to moderate to severe according to the VAS score.

  4. VAS score

    Time frame: 10-30 seconds

    Patients rate their pruritus according to the VAS scale.

  5. Ramsay score

    Time frame: 10-30 seconds

    Scoring of patients according to their mental status after administration of propofol.

Secondary outcomes

  1. Adverse reactions

    Time frame: 3-6 minutes

    Hypotension, respiratory depression, injection pain after propofol use, record it.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2021
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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