An interventional study of Spinal Anesthesia and Epidural Anesthesia in Cesarean Section, Pregnancy Related and Cerebral Hypoxia, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Not applicable, Interventional, and Prevention
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).
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.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Bursa Yüksek İhtisas Education and Research Hospital is the lead sponsor of 62 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Near infrared spectroscopy , neonatal peripheral oxygen saturation measurements and hemodynamic data will be compared between groups
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.
Time frame: on 10 minutes
Maternal mean arterial pressure
Maternal mean arterial pressure is monitored by non-invasive blood pressure measurement
Time frame: during cesarean section
Newborn vitalty
Newborn saturation are monitored with peripheral oxygen saturation(spo2,saturation sensor, Drager, Lübeck, Germany)
Time frame: 10 minutes after birth
Newborn vitalty
Newborn heart rate are monitored with pulse oximeter(heart rate sensor, Covidien, Dublin, Ireland
Time frame: 10 minutes after birth
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for May 2024, 1 month later.
Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's planned 1 month is below that.
Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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