Cesarean Delivery, Spinal Anesthesia for Cesarean Section
Conditions
Keywords
Cesarean delivery, Spinal anesthesia, Echocardiography, Hemodynamics
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.
Interventions
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
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
PROCEDURECesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
RADIATIONTransthoracic 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
DRUGIntravenous 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
DRUGIntravenous 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection | From the start of spinal anesthesia until delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Systolic blood pressure \<90% of baseline value |
| 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 | — |
| Incidence of severe hypotension | From the start of spinal anesthesia until delivery | Systolic blood pressure \<70% of baseline value |
| Incidence of bradycardia | From the start of spinal anesthesia until delivery | Heart rate \<50 beats/min |
| 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 | Scale from 0 to 10. Higher scores mean better outcomes. |
| Incidence of hypotension | From the start of spinal anesthesia until delivery | Systolic blood pressure \<80% of baseline value |
Countries
Egypt
Contacts
Primary ContactMohamed M Tawfik, MD
Outcome results
None listed