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The effect of lidocaine administration during general anesthesia on inflammatory prognostic scores in breast cancer surgery candidates

Protocol summary

Summary
(1) Objectives: Evaluating the effect of intravenous lidocaine infusion during surgery on inflammatory factor levels based on glasgow prognostic score and neutrophil to lymphocyte ratio in patients candidate for mastectomy due to breast cancer (2) Design: The present study is a double blind randomized clinical trial. All breast cancer patients with ASA: I, II referring to Imam Hosein hospital, Tehran, Iran, who were candidate for elective mastectomy were included. Totally 63 patients were allocated in to 2 groups of intervention (lidocaine) and control (normal saline) based on a random number table. (3) Setting and conduct: General anesthesia was induced similarly for all patients, using midazolam 0.02 mg/kg, fentanyl 2-4 µg/kg, propofol 1-2 mg/kg and atracurium 0.5 mg/kg. (4) Participants: Breast cancer patients candidate for elective mastectomy were included. History of renal or hepatic failure, cardiac dysrhythmia, hospital admission more than 5 days, infection in last 14 days, allergy to lidocaine, recent blood transfusion, blood transfusion during or after surgery, surgery duration more than 4 hours and drug abuse are exclusion criteria. (5) Intervention: In intervention group, 1.5 mg/kg/hr intravenous lidocaine and in control group, the same volume of normal saline was infused intravenously. (6) Main outcome measures: Glasgow prognostic score and neutrophil to lymphocyte ratio were calculated before surgery and 6, 24, 48 hours and 14 days after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608029593N5
Registration date: 2016-08-24, 1395/06/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-24, 1395/06/03
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
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lidocaine administration during general anesthesia on inflammatory prognostic scores in breast cancer surgery candidates
Public title
The effect of lidocaine administration during general anesthesia on inflammatory prognostic scores in breast cancer surgery candidates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Breast cancer patients candidate for elective mastectomy;ASA class I, II Exclusion criteria: History of epilepsy; psychotic disorders; using anti-psychotic drugs; hepatic failure; elevated liver enzymes;renal failure; cardiac dysrhythmia; hospital admission more than 5 days; infection in last 14 days; drug allergic reaction to lidocaine; blood transfusion in last week; blood transfusion during or after surgery; surgery duration more than 4 hours; drug abuse are exclusion criteria
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization using randomized number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Shahid Beheshti University of Medical Sciences
Street address
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Velenjak Street
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
IR.SBMU.SM.REC.1394.98

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
neutrophil to lymphocyte ratio
Timepoint
0, 6, 24, 48 hours and 14 days after surgery
Method of measurement
Calculation of the ratio by researcher

2

Description
Glasgow prognostic score
Timepoint
0, 6, 24, 48 hours and 14 days after surgery
Method of measurement
Calculation of the score by researcher

Secondary outcomes

1

Description
C reactive protein
Timepoint
0, 6, 24, 48 hours and 14 days after surgery
Method of measurement
Based on mg/dL using laboratory kit

2

Description
Albumin
Timepoint
0, 6, 24, 48 hours and 14 days after surgery
Method of measurement
Based on mg/dL using laboratory kit

3

Description
Complete blood count (CBC)
Timepoint
0, 6, 24, 48 hours and 14 days after surgery
Method of measurement
Based on count/mm3 using laboratory kit

Intervention groups

1

Description
After inducing anesthesia using midazolam 0.02 mg/kg, fentanyl 2-4 µg/kg, propofol 1-2 mg/kg and atracurium 0.5 mg/kg, in intervention group, 1.5 mg/kg/hr IV lidocaine was infused intravenously.
Category
Treatment - Drugs

2

Description
After inducing anesthesia using midazolam 0.02 mg/kg, fentanyl 2-4 µg/kg, propofol 1-2 mg/kg and atracurium 0.5 mg/kg, in control group, normal saline with the same volume and rate as 1.5 mg/kg/hr IV lidocaine was infused intravenously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Dr. Elham Memary
Street address
Shahid Madani Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziyayi
Street address
Vice chancellor for research, 3rd floor, Medical School, Shahid Beheshti University of Medical Sciences, Velenjak, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Elham Memary
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
drmemary@gmail.comdrmemary@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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