- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108937
Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro
October 8, 2017 updated by: RenJi Hospital
Effects of Serum From Patients Received Dexmedetomidine During General Anesthesia on Breast Cancer Cell Function in Vitro
Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.
Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.
Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or saline during surgery, we investigated the effects of dexmedetomidine on proliferation, migration and metastasis in MCF-7 breast cancer cells in vitro.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group.
Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia.
BIS value will be controlled between 40-60 during surgery.
Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery.
Patients of control group will receive same amount of normal saline.
Serum will be collected from patients of both groups at before induction and 1h post-surgery.
The MCF-7 breast cancer cell line will be treated with patient serum from both groups.
The effects of dexmedetomidine on cellular proliferation, migration and metastasis will be measured.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
-
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Shanghai
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Shanghai, Shanghai, China, 200127
- RenJi Hospital
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ASA grade I-III Age range of 18 to75 Patients diagnosed primary breast cancer(T2-3, N0-2, M0) Patients will have elective adenomammectomy
Exclusion Criteria:
- with history of breast operation Patients diagnosed carcinoma erysipelatodes Severe liver, renal, brain or lung disease with history of opioid addiction Patients diagnosed metastatic breast cancer
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dexmedetomidine
Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery.
|
Patients in the experimental group will receive Dexmedetomidine during surgery.
|
|
Placebo Comparator: saline
Same amount of saline will be administrated.
|
Patients in the control group will receive saline but not Dexmedetomidine during surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cell proliferation
Time Frame: 24 hour post-surgery
|
MCF-7 cells will be cultured with serum from patients of both groups for 24 hours and cell proliferation will be measured
|
24 hour post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cell migration
Time Frame: 24 hour post-surgery
|
MCF-7 cells will be cultured with serum from patients of both groups for 24 hours and cell migration will be measured
|
24 hour post-surgery
|
|
cell metastasis
Time Frame: 24 hour post-surgery
|
MCF-7 cells will be cultured with serum from patients of both groups for 24 hours and cell metastasis will be measured
|
24 hour post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 12, 2017
Primary Completion (Actual)
July 7, 2017
Study Completion (Actual)
September 8, 2017
Study Registration Dates
First Submitted
April 6, 2017
First Submitted That Met QC Criteria
April 10, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
October 10, 2017
Last Update Submitted That Met QC Criteria
October 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- DEX201703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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