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CSIABTEC: Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT00575354
Collaborator
(none)
500
Enrollment
1
Location
2
Arms
9
Duration (Months)
55.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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

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.
Other Names:
  • Sevofrane

    		•
    Active Comparator: 2

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Time of induction, maintenance and resuscitation [0h to the end of the operation]

    Secondary Outcome Measures

    1. Intraoperative hemodynamics; Postoperative side effects; [0h to 24h after the end of the operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chinese

    • Diagnosed benign breast tumor patients

    • 18-64 yrs

    Exclusion Criteria:

    • Allergic to any interventional drugs

    • Organic dysfunction

    • Long-lasting PACU staying

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nanjing Maternal and Child Care Hospital Nanjing Jiangsu China 210004

    Sponsors and Collaborators

    • Nanjing Medical University

    Investigators

    • Study Director: XiaoFeng Shen, MD, Nanjing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00575354
    Other Study ID Numbers:
    • NMU-2579-6FW
    • #NMU072036
    First Posted:
    Dec 18, 2007
    Last Update Posted:
    Apr 21, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Sevoflurane
    Isoflurane
    Breast tumor
    Anesthesia
    Additional relevant MeSH terms:
    Breast Neoplasms
    Sevoflurane
    Isoflurane

    Study Results

    No Results Posted as of Apr 21, 2008