Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns

Study Overview
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Brief Summary
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Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ systems. These adaptative changes may be affected such as type of delivery and anesthesia management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's cerebral and renal oxygenation in elective cesarean operations

Detailed Description
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The cases divided into two groups those spinal anesthesia group ( group:1; n:30 ) and general anesthesia group (group:2; n:30). The preoperative and intraoperative mean arterial pressures (MAP), heart rate (HR), arterial oxyhemoglobin saturation (SpO2), intraoperative blood loss values of pregnants and 1st-5th minute APGAR scores, preductal and postductal SpO2, perfusion index, heart rates, body temperature, cerebral and renal regional oxygen saturations of newborns after birth have been recorded.

Official Title
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Comparison of the Effects of Anesthetic Techniques Used for Cesarean Delivery on Neonatal Cerebral and Renal Oxygenation

Conditions
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Cesarean Delivery Affecting Newborn

Intervention / Treatment
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* Device: Near infrared spectroscopy (spinal anesthesia)
* Device: Near infrared spectroscopy (general anesthesia)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who undergo elective cesarean American Society of Anesthesiologists class 1 to 2 Ability to consent Gestational age: from 37 to 41 weeks Exclusion Criteria: Pulmonary disease History of allergic reaction to local anaesthetics Peripheral neuropathy Neurologic disease Coagulation disorders newborns with anomalies low birth weight newborns newborns needing neonatal resuscitation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spinal anesthesia<br>Patients in this group were randomized to receive spinal anesthesia. (Near infrared spectroscopy (spinal anesthesia)) | Device: Near infrared spectroscopy (spinal anesthesia)<br>* effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns<br>|
| Active Comparator: general anesthesia<br>Patients in this group were randomized to receive general anesthesia. (Near infrared spectroscopy (general anesthesia)). | Device: Near infrared spectroscopy (general anesthesia)<br>* effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal and cerebral regional oxygenation (rSO2) in newborn | Assessed at third and fifth minutes and then every 5 minutes after birth | 60 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preductal SpO2 | changes in preductal SpO2 after birth | 60 minutes after birth | 
| postductal SpO2 | changes in postductal SpO2 after birth | 60 minutes after birth | 
| perfusion index | changes in perfusion index after birth | 60 minutes after birth | 
| body temperature | changes in body temperature after birth | 60 minutes after birth | 
| apgar scores | changes in apgar scores after birth | 1st and 5th minute after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean, newborn, cerebral and renal oxygenation, anesthesia