Clinical trial NCT06316596: Brain Oxygenation in Newborns Due to Neuroaksial Methods
Official title: Evaluation Of Newborn Cerebral Oksigenation With Near Infrared Spectroscopy (NIRS) In Cesarean Section Surgeries Performed With Neuroaksial Blocks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section
Pregnancy Related
Cerebral Hypoxia
Anesthesia, Regional
Oxygen Saturation
Keywords: Anesthesia, Spinal
Anesthesia, Epidural
Newborn
Oxygen
Hypotension
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a prospective controlled,randomized,double-blind study
Primary purpose: PREVENTION

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Near İnfrared Spectroscopi
timeFrame: on 10 minutes
Secondary outcomes:
measure: Maternal mean arterial pressure
timeFrame: during cesarean section
measure: Newborn vitalty
timeFrame: 10 minutes after birth
measure: Newborn vitalty
timeFrame: 10 minutes after birth
Other outcomes:
Locations:
Study officials:
affiliation: gurahsen@gmail.com
name: Ahsen Gür Çelik
role: PRINCIPAL_INVESTIGATOR
References: