Anesthesia, Regional, Cerebral Hypoxia, Cesarean Section, Oxygen Saturation, Pregnancy Related
Conditions
Keywords
Anesthesia, Spinal, Anesthesia, Epidural, Newborn, Oxygen, Hypotension
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.
Interventions
PROCEDURESpinal Anesthesia
Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups
PROCEDUREEpidural Anesthesia
Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The research is a prospective, randomized, single-blind, parallel group study. In the study, the Quincke needle will be used for spinal anesthesia and the Tuoghy needle will be used for epidural anesthesia. Oxygenation will be evaluated with the help of NIRS probe in the post-cesarean newborns of pregnant women who will undergo elective cesarean section. Vitals will be monitored throughout the case with electrocardiography (ECG), non-invasive blood pressure monitoring and spO2. The amount of vasopressor agent and hydration required by the mother throughout the case will be recorded. While one anesthesiologist will monitor the anesthesia method and maternal vitals, the other anesthetist will monitor the NIRS monitoring attached to the newborn.
Intervention model description
The research is a prospective controlled,randomized,double-blind study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Near İnfrared Spectroscopi | on 10 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal mean arterial pressure | during cesarean section | Maternal mean arterial pressure is monitored by non-invasive blood pressure measurement |
| Newborn vitalty | 10 minutes after birth | Newborn saturation are monitored with peripheral oxygen saturation(spo2,saturation sensor, Drager, Lübeck, Germany) |
Contacts
Primary ContactAhsen Gür Çelik
Backup ContactDerya Karasu
Outcome results
None listed