Protocol summary
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Study aim
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Determining the effect of general and spinal anesthesia on serum level and gene expression of IL 4, 6, 10, 17, TGF-β and IFN-γ in maternal and umbilical cord blood in elective cesarean section
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Design
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Clinical trial with 2 parallel groups, single blind, randomised, 20 patients in each group
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Settings and conduct
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After entering women who are candidate for cesarean referred to Niknafs Hospital in Rafsanjan, An anesthesiologist will visit the patients. If there is no contraindication for SA or GA and none of the methods is preferred for the patient, the anesthesiologist will tell the patient about the research project. If the patient agrees to participate in the study, he will sign an informed consent form. Person who tests interleukin-assays, extracts RNA and synthesizes cDNA is blinded to the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 20 to 45, single pregnancy, term pregnancy and no complications such as chorioamnionitis and premature rupture of membrane. Exclusion criteria: unwanted pregnancy, a history of illness such as hypertension, diabetes, Cardiovascular disease, history of immunodeficiency diseases including HIV and hepatitis B, mental disorders, inflammatory diseases, drug use, smoking, alcohol and opium addiction
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Intervention groups
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Intervention group 1 (GA group): In this group induction of anesthesia will be performed using thiopental, 4-6 mg / kg sodium and succinylcholine, 1-1.5 mg /kg.
Intervention group 2 (SA): spinal anesthesia will be performd through injection of 0.5 ml marcaine (0.5% produced by AstraZeneca, Sweden) in the sub-arachnoid space using a quincke needle (produced in Japan), at the L3-L4 level in the sitting position.
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Main outcome variables
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mean and standard deviation of serum levels and gene expression of interleukins 4, 6, 10 and 17; TGF-β and IFN-γ in maternal and umbilical cord blood
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180304038943N1
Registration date:
2018-04-17, 1397/01/28
Registration timing:
prospective
Last update:
2018-11-05, 1397/08/14
Update count:
1
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Registration date
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2018-04-17, 1397/01/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-17, 1396/12/26
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Expected recruitment end date
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2018-04-09, 1397/01/20
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Actual recruitment start date
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2018-04-21, 1397/02/01
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Actual recruitment end date
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2018-06-22, 1397/04/01
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Trial completion date
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2018-06-23, 1397/04/02
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Scientific title
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Comparison of the effect of general and spinal anesthesia on serum level and gene expression of interleukin 4, 6, 10 and 17; TGF-β and IFN-γ in maternal and umbelical cord blood in elective cesarean section
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Public title
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The anesthesia effect on serum levels and gene expression of interleukins in elective cesarean section
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having reading and writing skills
being at the age of 20 to 45 years
single pregnancy
term pregnancy without complications such as Corioamnionitis and preterm rupture of membrane
Exclusion criteria:
Unwanted pregnancy
History of underlying illness including hypertension, diabetes, cardiovascular disease
History of immunodeficiency diseases including HIV and hepatitis B
mental disorders
Inflammatory diseases
History of drug abuse, smoking, Opium addiction
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned to General or spinal anesthesia groups using sealed envelopes (40 sealed envelopes, 20 of which were marked with G = general anesthesia and 20 with the sign S = spinal anesthesia).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The person who will perform tests to measure interleukins, extract RNA and synthesize cDNA will be kept blind to the study groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-01-09, 1395/10/20
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Ethics committee reference number
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IR.RUMS.REC.1395.125
Health conditions studied
1
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Description of health condition studied
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The effect of anesthesia technique on the immune system
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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serum level of interleukin 4 in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of IL-4 before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
2
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Description
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serum level of interleukin 6 in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of IL-6 before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
3
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Description
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serum level of interleukin 10 in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of IL-10 before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
4
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Description
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serum level of interleukin 17 in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of IL-17 before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
5
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Description
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serum level of interleukin IFN-γ in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of IFN-γ before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
6
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Description
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serum level of interleukin TGF-β in maternal blood before and after intervention
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Timepoint
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Measurement of serum level of TGF-β before study, after uterine incision, 2 hours after surgery, 24 hours after surgery
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Method of measurement
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ELISA test, Real Time PCR method
7
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Description
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Serum level of interleukin 4 in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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Elisa test, Real Time PCR method
8
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Description
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Serum level of interleukin 6 in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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ELISA test, Real Time PCR method
9
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Description
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Serum level of interleukin 10 in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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ELISA test, Real Time PCR method
10
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Description
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Serum level of interleukin 17 in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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ELISA test, Real Time PCR method
11
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Description
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Serum level of IFN-γ in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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ELISA test, Real Time PCR method
12
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Description
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Serum level of TGF-β in the umbilical cord blood of the baby
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Timepoint
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Immediately after birth
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Method of measurement
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ELISA test, Real Time PCR method
Secondary outcomes
1
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Description
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post operative pain
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Timepoint
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6, 12 and 24 hours after surgery
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Method of measurement
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Visual Analog Scale (VAS)
Intervention groups
1
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Description
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Intervention group 1 (general anesthesia group): In this group, after controlling the vital signs and administration of 100% oxygen using a mask and a pulse oximeter, induction of general anesthesia will be performed using thiopental, 4-6 mg / kg sodium and succinylcholine, 1-1.5 mg /kg. After tracheal intubation with Tube No. 7, oxygen and nitrous oxide are administered (50%). During the surgery Muscle relaxation will be performed using atracurium, 0.2-0.3 mg / kg.
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Category
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N/A
2
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Description
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Intervention group 2 (spinal anesthesia group): After controlling the vital signs, connecting the pulse oximeter's probe and starting the infusion of fluid, spinal anesthesia will be performd through injection of 0.5 ml marcaine (0.5% produced by AstraZeneca, Sweden) in the sub-arachnoid space using a quincke needle (produced in Japan), at the L3-L4 level in the sitting position. After administering the drug to the subarachnoid space, the patient will be placed immediately in the supine position.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rafsanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The gene expression, mean distribution and the standard deviation of interleukin in the two groups will share. Data will share without the attendee names.
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When the data will become available and for how long
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One year after publishing the results
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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Research centers
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From where data/document is obtainable
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hadavimaryam@yahoo.com
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What processes are involved for a request to access data/document
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Sending an email to the responsible author, after the qualification of the applicant for a maximum of two months
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Comments
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