NCT02768168

Brief Summary

The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

May 9, 2016

Last Update Submit

August 2, 2016

Conditions

Adverse Effect

Keywords

DezocineDexamethasone 21-phosphatePainPruritus

Outcome Measures

Primary Outcomes (1)

  • The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)

    In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Secondary Outcomes (1)

  • The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)

    In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Other Outcomes (1)

  • The duration of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)

    In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate

Study Arms (2)

Group D

EXPERIMENTAL

40 patients receive dezocine 0.1 mg/Kg

Drug: dezocine

Group C

PLACEBO COMPARATOR

40 patients receive matching placebo （normal saline）

Other: normal saline

Interventions

dezocineDRUG

receive dezocine 0.1 mg/kg

Group D
normal salineOTHER

receive matching placebo (equal volume of normal saline)

Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65 years
  • ASA physical status I-II
  • BMI 18-24.5 kg/m2

You may not qualify if:

  • On regular use of analgesic
  • Contraindication or allergy to steroid or dezocine
  • Drug or alcohol abuse
  • Diagnosed with paresthesia or mental diseases
  • Communication disorders
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

PainPruritus

Interventions

dezocineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Junwei Zheng

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)