Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age19-40
SponsorMansoura University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists physical status II.
Singleton, full term pregnancy.
Scheduled cesarean delivery under spinal anesthesia.
Disqualifiers
Height <150 or >180 cm.
Weight <60 or >110 kg.
Body mass index (BMI) <18.5 or ≥35 kg/m².
Women presenting in labor.
Trial design
Design model
Parallel
Treatments tested in this trial
Spinal Anesthesia with Bupivacaine and Fentanyl
Procedure/SurgerySpinal 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
Crystalloid Coload 1000 mL
DrugRinger acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean Delivery
Procedure/SurgeryLower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Transthoracic Echocardiography
RadiationMeasurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
Intravenous Norepinephrine Bolus
DrugProphylactic 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
Intravenous Ephedrine Bolus
DrugProphylactic 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: NorepinephrineExperimental treatment 5 interventions
Group B: EphedrineActive comparator 5 interventions
Trial outcomes
Primary outcomes
1
Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection
Time frame
From the start of spinal anesthesia until deliverySecondary outcomes
1
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 delivery2
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 delivery3
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 delivery4
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 deliverySponsors and contacts
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Source ClinicalTrials.gov