The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-11-30

Brief Summary

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patients may appear serious perineal itching, after injection of dexamethasone sodium phosphate injection its incidence is about 25% \~ 100%, and the incidence of the discomfort in females was much higher than that of the maleTo investigate the effect of propofol pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and explore the possible machanisms.

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Detailed Description

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40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I\~II,BMI 18\~30kg/m2 were selected in this study.The patients were equally randomized into two groups: propofol (P) group and normal saline (N) group, 20 cases in each group. Before anesthesia induction, M group received intravenous injection of 0.3mg/kg propofol , while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg. The anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups.

Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

propofol (P) group and normal saline (N) group

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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normal saline (N) group

Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.

propofol (P) group

Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.

Interventions

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Propofol

Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.

Intervention Type DRUG

normal saline

Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 \~ 30 kg/m2.

Exclusion Criteria

* diabetes mellitus, paresthesia, allergy to narcotic drugs, routine preoperative use of narcotic analgesics, long-term use of hormones, drug and alcohol abuse, communication disorders in psychiatric disorders, pregnancy or lactation, and patients with severe systemic diseases and unwilling to undergo the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No