The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT04337073

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Drug: Propofol Drug: normal saline	Early Phase 1

Detailed Description

40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I_II,BMI
1830kg/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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effect of Propofol on Dexamethasone-induced Perineal Pruritus

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: normal saline (N) group Before anesthesia induction, N group received corresponding intravenous normal saline of the same volume.	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.
Active Comparator: propofol (P) group Before anesthesia induction, P group received intravenous injection of 0.3mg/kg propofol	Drug: 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.

Arm

Intervention/Treatment

Placebo Comparator: normal saline (N) group

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

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.

Active Comparator: propofol (P) group

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

Drug: Propofol

Outcome Measures

Primary Outcome Measures

visual analogue scale(VAS) scores [in 3min]
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

Secondary Outcome Measures

the occurrence of adverse reactions [in 3min]
the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated hospital of yangzhou university	Yangzhou	Jiangsu	China	225100

Sponsors and Collaborators

Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ma Hong, Affiliated hospital of Yangzhou university, Yangzhou University

ClinicalTrials.gov Identifier:

NCT04337073

Other Study ID Numbers:

MHong

First Posted:

Apr 7, 2020

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ma Hong, Affiliated hospital of Yangzhou university, Yangzhou University

propofol; Dexamethasone; pruritus

Additional relevant MeSH terms:

Pruritus

Propofol

Study Results

No Results Posted as of Feb 25, 2022