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Efficacy and Optimal Dose Selection of Intranasal Dexmedetomidine During Breast Lumpectomy Under Local Anaesthesia

NCT02675049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-01

No results posted yet for this study

Summary

This trial is going to evaluate the safety and effectiveness of intranasal DEX(dexmedetomidine) in breast lumpectomy under local anaesthesia,and to investigate the optimal dose of intranasal DEX in breast lumpectomy.

Conditions

  • Intranasal Dexmedetomidine Breast Cancer Local Anaesthesia

Interventions

DRUG

0.9% saline

0.9% saline intranasally 45 min before surgery using a computer-generated random number table.

DRUG

dexmedetomidine 1µg.kg-1

dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

DRUG

dexmedetomidine 1.5µg.kg-1

Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

DRUG

Dexmedetomidine 2µg.kg-1

dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675049 on ClinicalTrials.gov