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Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision (CSIABTEC)
This study has been completed.
First Received: December 14, 2007   Last Updated: April 18, 2008   History of Changes
Sponsor: Nanjing Medical University
Information provided by: Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00575354
  Purpose

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 Intervention Phase
Breast Neoplasms
Drug: Sevoflurane
Drug: Isoflurane
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Time of induction, maintenance and resuscitation [ Time Frame: 0h to the end of the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraoperative hemodynamics; Postoperative side effects; [ Time Frame: 0h to 24h after the end of the operation ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
2: Active Comparator
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575354

Locations
China, Jiangsu
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
  More Information

No publications provided

Responsible Party: Nanjing Medical University ( XiaoFeng Shen )
Study ID Numbers: NMU-2579-6FW, #NMU072036
Study First Received: December 14, 2007
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00575354     History of Changes
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Sevoflurane
Isoflurane
Breast tumor
Anesthesia

Additional relevant MeSH terms:
Skin Diseases
Hematologic Agents
Physiological Effects of Drugs
Breast Neoplasms
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Sevoflurane
Anesthetics, Inhalation
Neoplasms
Neoplasms by Site
Anesthetics, General
Therapeutic Uses
Isoflurane
Platelet Aggregation Inhibitors
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009