Brain Oxygenation in Newborns Due to Neuroaksial Methods

Pregnancy Related Clinical Trial

— oxygenation  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316596
• Other study ID #: 2011-KAEK-25 2023/09-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Ahsen Gür Çelik
• Phone: +905071213621
• Email: gurahsen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Regional
• Cerebral Hypoxia
• Cesarean Section
• Hypoxia
• Hypoxia, Brain
• Oxygen Saturation
• Pregnancy Related

Intervention

Procedure:
• Spinal Anesthesia
Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups
• Epidural Anesthesia
Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

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