Investigate the effects of lidocaine infusion versus fentanyl on breast cancer cells apoptosis in patient under breast cancer surgery
Design
Clinical trial with two groups of lidocaine and fentanyl, with parallel groups, double blinded , randomized based on simple randomization, with 68 patients
Settings and conduct
The study will be performed as a blind in the branch of the person evaluating the outcome in 68 patients with breast cancer and candidates for surgery in Imam Hossein Hospital (1300-1499). Patients enter the study after entering the operating room and obtaining full consent and explanations on how to implement the plan. After monitoring, and before the start of anesthesia, 5 cc of blood samples are taken from the patients. Induction of anesthesia is the same for everyone. Patients were randomly divided into two groups of 34: lidocaine L and fentanyl F .In group L, lidocaine infusion (120 mg / hr) and in group F, fentanyl infusion at 2 µg / kg / h. Maintenance of anesthesia during surgery is similar in both groups. 1 hour after the end of surgery, a second venous blood sample (5 cc) is taken. The samples will be numbered and then sent to a pathology laboratory for apoptosis testing. Centrifuged sera will be exposed to cultured breast cancer cells at three time intervals in 12,24,48hr and the apoptosis index in both groups will be determined and compared.
Participants/Inclusion and exclusion criteria
The women between 18 to 75 ASA I,II, with breast cancer undergoing mastectomy
Intervention groups
Lidocaine group: Lidocaine infusion during anesthesia with a dose of (120mg / hr)
Fentanyl group: Fentanyl infusion during anesthesia with dose 2µg/kg/h
Main outcome variables
Apoptosis index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120430009593N14
Registration date:2021-01-19, 1399/10/30
Registration timing:prospective
Last update:2021-01-19, 1399/10/30
Update count:0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of lidocaine infusion versus fentanyl on breast cancer cells apoptosis in patient under breast cancer surgery
Public title
ٍEvalaution of anti-tumoral effects of sera isolated from lidocaine and fentanyl infusion in the patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female 18 to 75 years old candiadate for mastectomy due to breast cancer
ASA I,II
Exclusion criteria:
History of cardiac arrhythmias
ASA IV
Inflammation and infection at the surgical site
History of seizures
History of liver disease
History of previous breast surgery except than breast biopsy
Kidney failure
Addiction
History of mental illness
Age
From 18 years old to 75 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization unit: individual
Randomization tool: Randomization will be done using the site https://www.randomizer.org which using random numbers extracted by the software, patients will be given one of the two groups of lidocaine (L) and Fentanyl (F).
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be prepared and coded in advance by one of the researchers present in similar 50 cc syringes. The participants who will enter the study after approving the informed consent and after explaining how to group, will enter the study,with a table of random numbers assigned to one of the infusion groups of fentanyl or lidocaine and the drug in research adjusted rapidly by the anesthesiologist in the operating room, who is not part of the research team but will be aware of the type of drug, is injected at an adjusted rate based on the patient's weight and the type of drug. Patients' blood samples will be taken from all patients before induction of anesthesia and also one hour after surgery and will be sent to a laboratory for centrifugation and apoptosis index. Accordingly, patients and researchers (anesthesiologists and pathologists) are not aware of the type of drug and the relevant group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethical commite of Shahid Beheshti Medical University
Street address
Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Ebne Yaman St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-09-29, 1396/07/07
Ethics committee reference number
IR.SBMU.MSP.REC.1396.533
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Cancer Cell Apoptosis Index
Timepoint
Evaluation of apoptosis index in breast cancer cells after 12, 24 and 48 hours of serum exposure
Method of measurement
Measurement of Caspase 3, Caspase 8 and Caspase 9 factors based on immunocytochemical techniques
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Fentanyl infusion during anesthesia at a dose of 2 microg /kg until the end of surgery. Caspian Tamin Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group: Infusion at a dose of 120 mg per hour until the end of surgery. Caspian Tamin Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Elham Memary
Street address
Imam Hossein Hospital, Shahid Madani St, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drmemary@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzad Razaghi
Street address
University Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memary
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drmemary@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memary
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drmemary@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Memary
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hosspital, Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drmemary@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Some of data can be shared.
When the data will become available and for how long
Get started 6 month after printing results
To whom data/document is available
Surgeons and anesthesiologist and Academic Researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
Elham Memary via Email
What processes are involved for a request to access data/document
During an email and after its introduction, the type of expertise and explanation of the reason for requesting information, the files will be sent within 2 months