Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03594695
Other study ID # hsCRP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2018
Est. completion date August 20, 2018

Study information

Verified date October 2018
Source Ufuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 20, 2018
Est. primary completion date August 15, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
HSCRP and NLR
hs-CRP levels and NLR values will be studied from routine blood samples.

Locations

Country Name City State
Turkey Ufuk University Ankara Balgat

Sponsors (1)

Lead Sponsor Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the change in HSCRP levels Measurement of high sensitive C reactive protein levels in different time points in order to evaluate the change in HSCRP levels preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)
Primary Evaluation of the change in NLR Measurement of the Neutrophil to Lymphocyte Ratio in different time points in order to evaluate the change in the Neutrophil to Lymphocyte Ratios preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas