Recruiting NCT07322419
Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL, Cesarean Delivery, Transthoracic Echocardiography.
- Who it may be relevant to
- Registry conditions: Cesarean Delivery, Spinal Anesthesia for Cesarean Section. Basic parameters: 19 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Spinal Anesthesia with Bupivacaine and Fentanyl
Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace - Drug Crystalloid Coload 1000 mL
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection - Procedure Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization - Radiation Transthoracic Echocardiography
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery - Drug Intravenous Norepinephrine Bolus
Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively - Drug Intravenous Ephedrine Bolus
Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
Primary outcome measures
- 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 outcome measures (12)
- Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From the start of spinal anesthesia until delivery]
- Number of patients receiving rescue vasopressor [Time frame: From the start of spinal anesthesia until delivery]
- Incidence of hypotension [Time frame: From the start of spinal anesthesia until delivery]
- Incidence of severe hypotension [Time frame: From the start of spinal anesthesia until delivery]
- Incidence of bradycardia [Time frame: From the start of spinal anesthesia until delivery]
- Incidence of nausea and/or vomiting [Time frame: From the start of spinal anesthesia until delivery]
- Total vasopressor dose [Time frame: From the start of spinal anesthesia until delivery]
- Neonatal Apgar score at 1 and 5 minutes after delivery [Time frame: 1 and 5 minutes after delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals — Al Mansurah
Identifiers
NCT: NCT07322419 · MD.25.04.982