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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108937
Other study ID # DEX201703
Secondary ID
Status Completed
Phase N/A
First received April 6, 2017
Last updated October 8, 2017
Start date April 12, 2017
Est. completion date September 8, 2017

Study information

Verified date March 2017
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 8, 2017
Est. primary completion date July 7, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Patients in the experimental group will receive Dexmedetomidine during surgery.
saline
Patients in the control group will receive saline but not Dexmedetomidine during surgery.

Locations

Country Name City State
China Renji Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary cell proliferation 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 cell migration 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
Secondary cell metastasis 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
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