- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575354
Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision (CSIABTEC)
April 18, 2008 updated by: Nanjing Medical University
Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Care Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Chinese
- Diagnosed benign breast tumor patients
- 18-64 yrs
Exclusion Criteria:
- Allergic to any interventional drugs
- Organic dysfunction
- Long-lasting PACU staying
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Sevoflurane: induction 3-6%, maintenance 2-3%
|
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:
|
ACTIVE_COMPARATOR: 2
Isoflurane: induction 3-6%, maintenance 2-3%
|
3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of induction, maintenance and resuscitation
Time Frame: 0h to the end of the operation
|
0h to the end of the operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intraoperative hemodynamics; Postoperative side effects;
Time Frame: 0h to 24h after the end of the operation
|
0h to 24h after the end of the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 17, 2007
First Posted (ESTIMATE)
December 18, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
April 21, 2008
Last Update Submitted That Met QC Criteria
April 18, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-2579-6FW
- #NMU072036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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