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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pruritus Vulvae

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P1 group<br>Administration of 0.1 mg/kg of propofol and 5mg dexamethasone phosphate sodium | Drug: Propofol<br>* 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<br>|
| Experimental: P2 group<br>Administration of 0.2mg/kg of propofol and 5mg dexamethasone phosphate sodium | Drug: Propofol<br>* 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<br>|
| Experimental: P3 group<br>Administration of 0.3mg/kg of propofol and 5mg dexamethasone phosphate sodium | Drug: Propofol<br>* 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<br>|
| Experimental: P4 group<br>Administration of 0.4 mg/kg of propofol and 5mg dexamethasone phosphate sodium | Drug: Propofol<br>* 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<br>|
| Experimental: P5 group<br>Administration of 0.5mg/kg of propofol and 5mg dexamethasone phosphate sodium | Drug: Propofol<br>* 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<br>|
| No Intervention: D1 group<br>Administration of 5mg dexamethasone phosphate sodium | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of pruritus | After the administration of dexamethasone sodium phosphate, if pruritus occurs, record the beginning and end | 3-6 minutes | 
| Incidence of pruritus | Calculation of the occurrence of pruritus in each group. | 3-6 minutes | 
| Severity of pruritus | Pruritus is classified as mild to moderate to severe according to the VAS score. | 3-6 minutes | 
| VAS score | Patients rate their pruritus according to the VAS scale. | 10-30 seconds | 
| Ramsay score | Scoring of patients according to their mental status after administration of propofol. | 10-30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Hypotension, respiratory depression, injection pain after propofol use, record it. | 3-6 minutes |