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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Device: LMA®; Device: Endotracheal tube

• Registration Number: NCT00638599
• Lead Sponsor: Nanjing Medical University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	LMA®	LMA® is placed after anesthesia induction till the end of operation
2	Endotracheal tube	Standard tracheal tube is inserted after anesthesia induction till the end of operation

Primary Outcome Measures

Name	Time	Method
Circulatory Homeostasis	15min prior to operation to 15min posterior to operation

Secondary Outcome Measures

Name	Time	Method
Airway complications	Start of operation to 6h after operation
Airway pressure	15min prior to operation to 15min posterior to operation
Blood gas	15min prior to operation to 15min posterior to operation

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China