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Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

NCT ID: NCT00575354

Last Updated: 2008-04-21

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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Generally, benign breast tumors are excised under the local anesthesia. But such action was so invasive that every patient would experience the physiological and psychological stimuli unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its "easy come,easy go" property during short-lasting operations than isoflurane. We purposed that sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane with relative less alteration in hemodynamics, less postoperative side effects and easily-control the depth of anesthesia.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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Sevoflurane Isoflurane Breast tumor Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Sevoflurane: induction 3-6%, maintenance 2-3%

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.

2

Isoflurane: induction 3-6%, maintenance 2-3%

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.

Interventions

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Isoflurane

3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.

Intervention Type DRUG

Sevoflurane

3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.

Intervention Type DRUG

Other Intervention Names

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Sevofrane

Eligibility Criteria

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Inclusion Criteria

* Chinese
* Diagnosed benign breast tumor patients
* 18-64 yrs

Exclusion Criteria

* Allergic to any interventional drugs
* Organic dysfunction
* Long-lasting PACU staying
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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 Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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#NMU072036

Identifier Type: -

Identifier Source: secondary_id

NMU-2579-6FW

Identifier Type: -

Identifier Source: org_study_id