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| 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 |
| 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.
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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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Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Jiangsu | |
| Nanjing Maternal and Child Care Hospital | |
| Nanjing, Jiangsu, China, 210004 | |
| Study Director: | XiaoFeng Shen, MD | Nanjing Medical University |
More Information
| 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 |
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Sevoflurane Isoflurane Breast tumor Anesthesia |
|
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 |