A Phase 4 interventional study of Epinephrine 0.03 and Epinephrin 0.02 in Postspinal Hypotension, Cesarean Delivery and Epinephrine, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Prevention
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.
Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.
In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.
Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 276 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Drug: Epinephrine 0.03
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Drug: Epinephrin 0.02
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Drug: Epinephrin 0.01
epinephrine infusion rate of 0.03 mcg/kg/min
Also known as: adrenaline
epinephrine infusion rate of 0.02 mcg/kg/min
Also known as: adrenaline
epinephrine infusion rate of 0.01 mcg/kg/min
Also known as: adrenaline
incidence of postspinal hypotension
systolic blood pressure ≤80% of the baseline reading
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of tachycardia
heart rate \> 130% of baseline
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of hypertension
systolic blood pressure \>120% of baseline
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of severe hypotension
systolic blood pressure ≤60% of the baseline reading
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mean heart rate
beat per minute
Time frame: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mean systolic blood pressure
mmHg
Time frame: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
total ephedrine requirement
mg
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
total atropine requirement
mg
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
Apgar score
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
Time frame: 5 minutes after delivery
umbilical blood pH
pH
Time frame: 5 minutes after delivery
umbilical blood PCO2
mmHg
Time frame: 5 minutes after delivery
umbilical blood PO2
mmHg
Time frame: 5 minutes after delivery
umbilical blood HCO3
mmol/L
Time frame: 5 minutes after delivery
Plan to share: No — Available from PI upon reasonable request
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Kasr El Aini Hospital