Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer

NCT ID: NCT00638599

Last Updated: 2009-07-15

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

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-07-31

Brief Summary

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Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

LMA® is placed after anesthesia induction till the end of operation

Group Type EXPERIMENTAL

LMA®

Intervention Type DEVICE

LMA® is placed after anesthesia induction and removed after the operation

2

Standard tracheal tube is inserted after anesthesia induction till the end of operation

Group Type ACTIVE_COMPARATOR

Endotracheal tube

Intervention Type DEVICE

Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

Interventions

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LMA®

LMA® is placed after anesthesia induction and removed after the operation

Intervention Type DEVICE

Endotracheal tube

Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chinese
* Diagnosed breast cancer
* Undergoing modified radical mastectomy
* Agreed to participate the study with informed contract.

Exclusion Criteria

* Organic dysfunction
* Long-lasting post-anesthetic care unit(PACU) staying.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NMU075451

Identifier Type: -

Identifier Source: secondary_id

NMU-2579-7FW

Identifier Type: -

Identifier Source: org_study_id

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