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Sponsored by: |
Nanjing Medical University |
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Information provided by: | Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT00575354 |
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 |
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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 |
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 |
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1: Active Comparator
Sevoflurane: induction 3-6%, maintenance 2-3%
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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.
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2: Active Comparator
Isoflurane: induction 3-6%, maintenance 2-3%
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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.
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
Nanjing Maternal and Child Care Hospital | |
Nanjing, Jiangsu, China, 210004 |
Study Director: | XiaoFeng Shen, MD | Nanjing Medical University |
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 |
Health Authority: | China: Ethics Committee |
Sevoflurane Isoflurane Breast tumor Anesthesia |
Skin Diseases Benzocaine Isoflurane |
Breast Neoplasms Breast Diseases Sevoflurane |
Anesthetics, Inhalation Neoplasms Neoplasms by Site Anesthetics, General Therapeutic Uses Hematologic Agents |
Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Platelet Aggregation Inhibitors Central Nervous System Agents Pharmacologic Actions |