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临床试验/NCT06316596
NCT06316596Unknown不适用

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

Bursa Yuksek Ihtisas Training and Research Hospital0 个研究点目标入组 80 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Near İnfrared Spectroscopi

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

NEWBORN BORN AFTER EPIDURAL ANESTHESIA

Active Comparator

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.

干预措施: Epidural Anesthesia (Procedure)

NEWBORN BORN AFTER SPINAL ANESTHESIA

Active Comparator

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.

干预措施: Spinal Anesthesia (Procedure)

结局指标

主要结局

Near İnfrared Spectroscopi

时间窗: 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.

次要结局

  • Maternal mean arterial pressure(during cesarean section)
  • Newborn vitalty(10 minutes after birth)

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahsen Gur Celik

Doctor of anesthesiology and reanimation

Bursa Yuksek Ihtisas Training and Research Hospital

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