NCT00575354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

9 months

First QC Date

December 14, 2007

Last Update Submit

April 18, 2008

Conditions

Breast Neoplasms

Keywords

SevofluraneIsofluraneBreast tumorAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Time of induction, maintenance and resuscitation

    0h to the end of the operation

Secondary Outcomes (1)

  • Intraoperative hemodynamics; Postoperative side effects;

    0h to 24h after the end of the operation

Study Arms (2)

1

ACTIVE COMPARATOR

Sevoflurane: induction 3-6%, maintenance 2-3%

Drug: Sevoflurane

2

ACTIVE COMPARATOR

Isoflurane: induction 3-6%, maintenance 2-3%

Drug: Isoflurane

Interventions

SevofluraneDRUG

3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.

Also known as: Sevofrane
1
IsofluraneDRUG

3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.

2

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese
  • Diagnosed benign breast tumor patients
  • yrs

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

SevofluraneIsoflurane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

CN(1)