Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision - Tabular View

Tracking Information

First Received Date ^ICMJE

December 14, 2007

Last Updated Date

April 18, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00575354 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

Official Title ^ICMJE

Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: Sevoflurane
Drug: Isoflurane

Study Arms / Comparison Groups

Active Comparator: Sevoflurane: induction 3-6%, maintenance 2-3%
Active Comparator: Isoflurane: induction 3-6%, maintenance 2-3%

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chinese
Diagnosed benign breast tumor patients
18-64 yrs

Exclusion Criteria:

Allergic to any interventional drugs
Organic dysfunction
Long-lasting PACU staying

Gender

Female

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00575354

Responsible Party

XiaoFeng Shen, Nanjing Medical University

Study ID Numbers ^ICMJE

NMU-2579-6FW, #NMU072036

Study Sponsor ^ICMJE

Nanjing Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

XiaoFeng Shen, MD

Nanjing Medical University

Information Provided By

Nanjing Medical University

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP