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

  • China
    • 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%
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.
Other Names:
  • Sevofrane
ACTIVE_COMPARATOR: 2
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.

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

Nanjing Medical University

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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