Clinical trial NCT03594695: Hs-CRP and NLR as Markers of Perioperative Stress
Official title: Hs-CRP and NLR as Markers of Perioperative Stress in Maternal And Fetal Blood in Different Anesthesia Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Delivery Affecting Newborn
Anesthesia
Inflammatory Response
Keywords: cesarean section, anesthesia, hs-CRP, NLR
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy).

Brief summary: The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Detailed description: The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response. Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The degree of systemic inflammation has been determined by numerous pro- and anti-inflammatory cytokines.The cytokines control the release of C -reactive protein (CRP) which is an acute phase reactant produced by the liver. CRP is a widely used marker of inflammation and tissue damage. High sensitive C -reactive protein (hs-CRP), is a more sensitive assay for detection of inflammation measured by particle-enhanced immunonephelometry . A rapid increase in hs-CRP may indicate inflammation and tissue damage . Another well-known indicator of inflammation is neutrophil-to-lymphocyte ratio (NLR). NLR correlates strongly with elevated plasma levels of circulating proinflammatory cytokineS. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy)

Exclusion Criteria:

* refusal to participate,
* chronic diseases (diabetes mellitus, hypertension, heart disease, renal disease, hypo/hyperthyroidism)
* any infections,
* smoking
* contraindications for central neuraxial anesthesia.
* Pregnancies complicated with rupture of membranes, placenta previa, eclampsia/preeclampsia, and abruptio placenta
* fetal anomalies,
* abnormality detected at fetal well-being tests

Primary outcomes:
measure: Evaluation of the change in HSCRP levels
timeFrame: preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)
measure: Evaluation of the change in NLR
timeFrame: preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
state: Balgat
Study officials:
affiliation: Ufuk University
name: Hakan Yılmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Jiang S, Wu Y. Effect of 2 different anesthesia methods on stress response in neurosurgical patients with hypertension or normal: A prospective clinical trial. Medicine (Baltimore). 2016 Aug;95(35):e4769. doi: 10.1097/MD.0000000000004769.
citation: Farzadnia M, Ayatollahi H, Hasan-Zade M, Rahimi HR. A comparative study of vascular cell adhesion molecule-1 and high-sensitive C-reactive protein in normal and preeclamptic pregnancies. Interv Med Appl Sci. 2013 Mar;5(1):26-30. doi: 10.1556/IMAS.5.2013.1.5. Epub 2013 Mar 19.