The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

NCT04337073 | Completed Early Phase 1

• 1 other identifier: MHong
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pruritus

Keywords

propofol; Dexamethasone; pruritus

Outcome Measures

Primary Outcomes (1)

• visual analogue scale(VAS) scores

  VAS score was used to grade the degree of perineal itching: VAS 0 was no discomfort, 1-3 was mild, 4-6 was moderate, and 7-10 was severe

  in 3min

Secondary Outcomes (1)

• the occurrence of adverse reactions

  in 3min

Study Arms (2)

normal saline (N) group

PLACEBO COMPARATOR

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

Drug: normal saline

propofol (P) group

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Propofol 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

normal saline 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.

normal saline (N) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

Affiliated hospital of yangzhou university

Yangzhou, Jiangsu, 225100, China

Location

MeSH Terms

Conditions

Pruritus

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated hospital of Yangzhou university

Model Details: propofol (P) group and normal saline (N) group

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: November 30, 2020
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)