Kasr Alaini hospital
Cairo, Egypt
Location status: Recruiting
Location contact
Dina A Turki, MD of anesthesia
PRINCIPAL_INVESTIGATOR
abdelkhalek m Samy
CONTACT
NCT Number: NCT07480889
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.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Phase 3
Cairo, Egypt
Location status: Recruiting
Dina A Turki, MD of anesthesia
PRINCIPAL_INVESTIGATOR
abdelkhalek m Samy
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.
Time frame: 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
Time frame: up to 2 hours after spinal anaesthesia
systolic blood pressure drop >30% from baseline or systolic blood pressure<80 mmHg
Time frame: up to 2 hours after spinal anaesthesia
Time frame: up to 2 hours after spinal anaesthesia
Time frame: up to 2 hours after spinal anaesthesia
Time frame: up to 2 hours after spinal anaesthesia
Time frame: up to 2 hours after spinal anesthesia
Time frame: up to 2 hours after spinal anaesthesia
Time frame: up to 5 minutes after fetal delivery
Umbilical artery blood gases obtained after delivery at 1 and 5 minutes
Time frame: 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).
Cairo University
Other
Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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