A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-09-30

Brief Summary

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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. The purpose of present study is to examine whether utilization of dexmedetomidine in patients undergoing surgery for primary breast cancer increases breast cancer recurrence and metastasis, and to investigate its effects on the patients' immune system.

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Detailed Description

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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. Patients will be followed up for 36 months to measure the incidence of cancer recurrence and metastasis. Serum form patients of both groups will be collected at 24 h after surgery. The number of CD3+ , CD4+, CD8+ cells and NK cells in the serum will be compared between the two groups. Serum levels of IFN-γ, IL-12，IL-4 and VEGF will also be measured and compared.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Patients of dexmedetomidine group will receive a loading dose 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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Patients in the experimental group will receive Dexmedetomidine during surgery.

saline

Same amount of saline will be administrated.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

Patients in the experimental group will receive Dexmedetomidine during surgery.

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA grade I-III
* Age range of 18 to75
* Patients diagnosed primary breast cancer
* Patients will have elective mastectomy

Exclusion Criteria

* with history of breast operation
* Patients diagnosed with inflammatory breast
* Severe mental or physical illnesses(like liver, renal, brain or lung disease)
* with history of opioid addiction
* Patients diagnosed metastatic breast cancer
* Contradictions or an allergy to Dexmedetomidine

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No