None listed
Conditions
Brief summary
During spinal, changes in respiratory function occur and resulting in impaired maternal-foetal gas exchange so that oxygen supplementation is commonly given to prevent maternal oxyhaemoglobin desaturation and to optimize fetal oxygenation. Changes in lung capacity, the mother and the fetus also causes decreased oxygen delivery to both uteroplacental hypoperfusion and fetal distress. However, the optimal maternal and intrauterine foetal arterial oxygen content before delivery during a routine caesarean section is not known. Many pregnant women are empirically given supplemental oxygen intraoperatively at least until the delivery of the baby. In addition, oxygen is a potentially toxic substance and could conceivably present a risk to both fetus and mother. For these reasons, it is important to establish whether health benefits may be derived from the use of oxygen for this purpose. We aimed to investigate the effect of 31%, 40% and 60% oxygen supplementation on maternal tissue oxygenation in elective cesarean section (CS) under spinal anesthesia.
Interventions
All patients will randomized with the closed envelope method.
All patients will be monitored and the basal vital functions (HR, SpO2, NIBP and StO2) will be recorded with admission into the OR.
All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach, at a level of L3-L4, with a 25 G Quincke type spinal needle and 2.5 ml hyperbaric bupivacaine.
After succesful administration of anesthesia, all patients will be placed into supine position
All patients will randomized with the closed envelope method. All patients will be monitored and the basal vital functions (HR, SpO2, NIBP and StO2) will be recorded with admission into the OR. All patients will placed into a sitting position and spinal anesthesia will be performed with a median approach, at a level of L3-L4, with a 25 G Quincke type spinal needle and 2.5 ml hyperbaric bupivacaine. After succesful administration of anesthesia, all patients will be placed into supine position, monitored and administered oxygene via a venturi mask after administration of spinal anesthesia until the completion of surgery in different inspirated fractions (31%, 40% and 60%) and all vital functions will be recorded (HR, SpO2, NIBP and StO2) after spinal anesthesia (in minute 1, 3 and 5), with the beginning of surgery (in minute 5, 10, 15, 20, 25, 30 and 40), after the end of surgery (in minute 5, 10, 15, 30 and 60) and in the 24th hour postoperatively Beside this, hemoglobin levels will be evaluated preoperatively, during surgery and postoperatively in the 30th and 60th minute, by a noninvasive continuous monitoring device. Spinal block levels, duration of surgery, APGAR scores, vasopressor consumption will be recorded.
Sponsors
Harran University School of Medicine, Research and Training Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
ASA physical status I–II term parturients undergoing elective CS under spinal anesthesia
Exclusion criteria
ASA status; > II Coexisting disease; metabolic, endocrine, hepatic, cardiac or renal diseases, malignancies, preeclampsia; hypertension; Concurrent medication used; or recent use (within 48h) of any drug with anti-oxidant properties such as nebivolol, carvedilol, vitamins E and C, or acetylcysteine
Outcome results
None listed