Hemodynamic (MAP) Stability
Conditions
Brief summary
In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Phenylephrine infusion is an important therapeutic strategy for preventing spinal-induced hypotension (SIH) in cesarean delivery, as it decreases the incidence of hypotension, nausea, and vomiting. However, high doses may reduce maternal heart rate and cardiac output in a dose-dependent manner. Ephedrine, previously considered the first-choice drug, has both α and β receptor agonistic activity and causes norepinephrine release from sympathetic neurons. Its β1 effect increases heart rate and contractility, but may cause undesirable tachycardia. Tachyphylaxis can develop with repeated doses. Norepinephrine, the biosynthetic precursor of epinephrine, has both potent α and weak β agonist effects, tending to cause bradycardia. Despite a lower incidence of hypotension with prophylactic norepinephrine, PSH still occurs in up to 30% of parturients undergoing cesarean section. The administration of a bolus dose of epinephrine prior to continuous infusion is an unusual practice in obstetric anesthesia, but has been reported to be safe in other contexts and in pregnant women when used for hemodynamic support. Epinephrine has both potent α- and β-adrenoceptor agonist activity. Its β effects could offset reflex decreases in maternal HR and CO during spinal anesthesia for cesarean delivery. Although some studies compared epinephrine infusion with phenylephrine, it remains unclear whether adding an initial bolus of epinephrine before infusion offers superior maternal hemodynamic stability compared to infusion alone.
Interventions
DRUGEpinephrine (Adrenaline) bolus then infusion
A bolus of 4 mcg epinephrine will be given just after spinal anaesthesia followed by 0.03 mcg/kg/min infusion which is equivalent to 1.8 mcg/kg/hr. Epinephrine dose of 3000 mcg will be diluting in 500 mL saline (6 mcg/mL), and the infusion rate will be set on 0.3 mL/kg/hr.
DRUGEpinephrine (Adrenaline) infusion
Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 to 35 years. 2. American Society of Anesthesiologists (ASA) physical status II. 3. Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.
Exclusion criteria
1. Uncontrolled cardiac morbidities as reduction of ejection fraction\< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents 2. Poorly controlled Hypertensive disorders of pregnancy 3. Peripartum bleeding 4. Multiple pregnancies (e.g., twin gestations) 5. Coagulation disorders defined as platelet count \<100,000/μL, INR \>1.4, or known inherited clotting factor deficiency. 6. Baseline systolic blood pressure (SBP) \< 100 mmHg or \>130 mmHg 7. Refusal of patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-spinal hypotension | up to 2 hours after spinal anesthesia | defined as systolic blood pressure drop \>20% from baseline, measured from block onset until 5 minutes after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe post-spinal hypotension | up to 2 hours after spinal anaesthesia | systolic blood pressure drop \>30% from baseline or systolic blood pressure\<80 mmHg |
| Number of hypotensive and severe hypotensive episodes per patient | up to 2 hours after spinal anaesthesia | — |
| Incidence of reactive hypertension (systolic blood pressure ≥ 120% of baseline) | up to 2 hours after spinal anaesthesia | — |
| Number of reactive hypertension episodes per patient | up to 2 hours after spinal anaesthesia | — |
| Incidence of tachycardia (heart rate >130% baseline, not related to hypotension) | up to 2 hours after spinal anaesthesia | — |
| Incidence of intraoperative nausea and vomiting | up to 2 hours after spinal anesthesia | — |
| Total intraoperative norepinephrine consumption | up to 2 hours after spinal anaesthesia | — |
| Fetal outcomes: umbilical artery blood gases | up to 5 minutes after fetal delivery | Umbilical artery blood gases obtained after delivery at 1 and 5 minutes |
| • Fetal outcomes: Apgar scores | up to 5 minutes after delivery | Apgar scores at 1 and 5 minutes after delivery Appearance (Skin color: 0=Blue/Pale, 1=Pink body/blue limbs, 2=All pink) Pulse (Heart rate: 0=None, 1=\<100 bpm, 2=\>100 bpm) Grimace (Reflex irritability: 0=None, 1=Grimace, 2=Cry/vigorous reaction) Activity (Muscle tone: 0=Limp, 1=Some flexion, 2=Active motion) Respiration (Breathing: 0=None, 1=Weak/irregular, 2=Strong cry) Interpretation: 7-10: Normal (reassuring). 4-6: Fair/Abnormal (may require stimulations or oxygen). 0-3: Low/Critically low (indicates need for intensive resuscitation). |
Countries
Egypt
Outcome results
None listed