Brain Oxygenation in Newborns Due to Neuroaksial Methods (oxygenation)

Evaluation Of Newborn Cerebral Oksigenation With Near Infrared Spectroscopy (NIRS) In Cesarean Section Surgeries Performed With Neuroaksial Blocks

Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS).

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Cesarean Section; Anesthesia, Regional; Oxygen Saturation; Cerebral Hypoxia
• Intervention / Treatment: Procedure: Epidural Anesthesia; Procedure: Spinal Anesthesia

Detailed Description

In all newborns, cerebral oxygen goes through a complex process as it moves from the fetus to the newborn stage. The type of delivery, anesthesia management, maternal factors before and during birth, and fetal malformations vary in the time it takes for arterial oxygen saturation to reach the expected level in the transition from the fetus to the newborn stage. NIRS is a regional oxygenation monitoring technique and measures regional oxygen saturation. NIRS can also be used as a non-invasive monitoring technique for cerebral oxygenation and hemodynamics. The transparency of tissue to infrared light (spectrum 700-1000 nm) and the formation of oxygenated hemoglobin (O2Hb) and deoxygenated hemoglobin in cerebral blood vessels within the infrared light.

It is based on absorption by (HHb). Hypotension due to sympathetic system blockade is a common finding in neuraxial blocks. Preventing hypotension in pregnancy and prompt intervention when it develops are important to prevent fetal complications. Determining the best neuraxial method in terms of hemodynamics will guide clinicians in practical use. 80 pregnant women between the ages of 18-35 who are scheduled for cesarean section and newborns after cesarean section will be included in the study. Study randomization will be done in sealed envelopes using computer generated randomization codes by a doctor who will not be involved in newborn baby care. For the quality and standardization of the block, it will be performed by an anesthesiologist experienced in spinal and epidural anesthesia. Pregnant heart rate, blood pressure, and saturation values are recorded at regular intervals, and when there is a 25% or more decrease in blood pressure compared to the initial value, iv ephedrine will be administered to the patient. If the heart rate is 25% and In case of a fall on the baby, iv atropine will be administered. After birth, the newborn will be placed in a pre-heated radiant warmer and normal newborn care will be provided by the newborn team, as is done routinely. A NIRS probe and a right-hand transcutaneous pulse oximeter (spO2) will be attached to the left and right frontal regions of the newborn by another anesthetist (anesthesia technique: blind) participating in the study, other than the person performing the neuraxial block, and the measurements will be recorded by the same person.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahsen Gür Çelik; Phone Number: +905071213621; Email: gurahsen@gmail.com
• Study Contact Backup: Name: Derya Karasu; Phone Number: +905057281175; Email: drderyatopuz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women between the ages of 18-35 and newborns after cesarean section
• Newborns born >37 weeks of gestation
• ASA II pregnant women

Exclusion Criteria:

• Previous local anesthetic allergy
• Those with bleeding diathesis disorder
• Having a mental disorder
• Those who are allergic to the drugs used
• Patients who did not consent to participate in the study
• Height <1.55 meters. or >1.70 meters.
• Presence of infection in the block area
• Body mass index >35 kg/m²
• Those with gestational hypertension and SAP>140 mmHg or DAP>90 mmHg in three pre-pregnancy measurements
• Known presence of fetal anomaly
• Those with known placenta pathology
• Those with a history of fetal anomaly and abnormal birth in previous pregnancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NEWBORN BORN AFTER EPIDURAL ANESTHESIA; Group epidural, 0.5% buvasin® will be applied epidural space in the lateral position after monitoring. The patient will be placed in the supine position and surgery will begin when the T5 spinal level is achieved. Pregnant heart rate, blood pressure and saturation values will be recorded at intervals and iv ephedrine will be administered when there is a 25% or more drop in blood pressure. When there is a 25% or more decrease in heart rate, iv atropine will be administered. A NIRS probe (infant,saturation sensor, Invos , Tullamore, Ireland) and pulse will be attached to the newborn by another anesthetist and the measurements will be recorded. Blood pressure will be taken from the umbilical vein. APGAR(activity,pulse,grimace,appearance,respiration), heart rate, SpO2 and umbilical vein saturation values of the newborn will be recorded. NIRS and spO2 values of the newborn will be checked intermittently.	Procedure: Epidural Anesthesia; Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups
Active Comparator: NEWBORN BORN AFTER SPINAL ANESTHESIA; Group spinal, 0.5% buvasin® heavy will be applied spinal space in the lateral position after monitoring. Surgery will begin when the patient is placed in the supine position and T5 spinal level is achieved. Pregnant heart rate, blood pressure, and saturation values are recorded at regular intervals, and when there is a 25% or more drop in blood pressure, the patient will be given iv ephedrine. When there is a 25% or more drop in heart rate, iv atropine will be administered. A NIRS probe (infant,saturation sensor, Invos , Tullamore, Ireland) and pulse will be attached to the newborn by another anesthetist and the measurements will be recorded. Blood pressure will be taken from the umbilical vein. The newborn's APGAR(activity,pulse,grimace,appearance,respiration), heart rate, SpO2 and umbilical venous saturation values will be recorded. NIRS and spO2 values will be checked intermittently.	Procedure: Spinal Anesthesia; Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near İnfrared Spectroscopi	Near Infrared Spectroscopy (NIRS,infant,saturation sensor, Invos , Tullamore, Ireland) monitors hemodynamic activity in the brain, offering the potential for cerebral monitoring in the region of interest.NIRS is a probe-guided device used for brain oxygenation in newborns.	on 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal mean arterial pressure	Maternal mean arterial pressure is monitored by non-invasive blood pressure measurement	during cesarean section
Newborn vitalty	Newborn saturation are monitored with peripheral oxygen saturation(spo2,saturation sensor, Drager, Lübeck, Germany)	10 minutes after birth
Newborn vitalty	Newborn heart rate are monitored with pulse oximeter(heart rate sensor, Covidien, Dublin, Ireland	10 minutes after birth

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Ahsen Gür Çelik, gurahsen@gmail.com

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypotension; Newborn; Oxygen; Anesthesia, Spinal; Anesthesia, Epidural
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Hypoxia, Brain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2011-KAEK-25 2023/09-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No