NCT07322419RecruitingPhase 4
Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Mansoura University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Study Overview
Brief Summary
Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists physical status II.
- •Singleton, full term pregnancy.
- •Scheduled cesarean delivery under spinal anesthesia.
Exclusion Criteria
- •Height <150 or >180 cm.
- •Weight <60 or >110 kg.
- •Body mass index (BMI) <18.5 or ≥35 kg/m².
- •Women presenting in labor.
- •Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
- •Chronic or pregnancy-induced hypertension.
- •Baseline systolic blood pressure >140 mm Hg.
- •Hemoglobin <10 g/dl.
- •Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease.
- •Polyhydramnios or known significant fetal abnormalities.
- •Current administration of vasoactive drugs such as: beta blockers, salbutamol, or thyroxin.
Arms & Interventions
Norepinephrine
Experimental
Intervention: Cesarean Delivery (Procedure)
Norepinephrine
Experimental
Intervention: Crystalloid Coload 1000 mL (Drug)
Norepinephrine
Experimental
Intervention: Spinal Anesthesia with Bupivacaine and Fentanyl (Procedure)
Norepinephrine
Experimental
Intervention: Transthoracic Echocardiography (Radiation)
Norepinephrine
Experimental
Intervention: Intravenous Norepinephrine Bolus (Drug)
Ephedrine
Active Comparator
Intervention: Spinal Anesthesia with Bupivacaine and Fentanyl (Procedure)
Ephedrine
Active Comparator
Intervention: Crystalloid Coload 1000 mL (Drug)
Ephedrine
Active Comparator
Intervention: Cesarean Delivery (Procedure)
Ephedrine
Active Comparator
Intervention: Transthoracic Echocardiography (Radiation)
Ephedrine
Active Comparator
Intervention: Intravenous Ephedrine Bolus (Drug)
Outcomes
Primary Outcomes
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Time Frame: From the start of spinal anesthesia until delivery
Secondary Outcomes
- Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery(From the start of spinal anesthesia until delivery)
- Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery(From the start of spinal anesthesia until delivery)
- Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery(From the start of spinal anesthesia until delivery)
- Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery(From the start of spinal anesthesia until delivery)
- Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery(From the start of spinal anesthesia until delivery)
- Number of patients receiving rescue vasopressor(From the start of spinal anesthesia until delivery)
- Incidence of hypotension(From the start of spinal anesthesia until delivery)
- Incidence of severe hypotension(From the start of spinal anesthesia until delivery)
- Incidence of bradycardia(From the start of spinal anesthesia until delivery)
- Incidence of nausea and/or vomiting(From the start of spinal anesthesia until delivery)
- Total vasopressor dose(From the start of spinal anesthesia until delivery)
- Neonatal Apgar score at 1 and 5 minutes after delivery(1 and 5 minutes after delivery)
Investigators
Mohamed Mohamed Tawfik
Associate Professor
Mansoura University
Study Sites (1)
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