Anesthesia, Spinal, Cesarean Section
Conditions
Brief summary
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
Detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
Interventions
DRUG500 mL Colloid Preload
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
PROCEDURESpinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Fentanyl 15 µg will be administered in the subarachnoid space
DRUG500 mL Crystalloid Coload
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
DRUG1000 mL Crystalloid Coload
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
PROCEDURECesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, 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 parturients * Full term, singleton pregnancy * Elective cesarean delivery under spinal anesthesia
Exclusion criteria
* Age \<19 or \> 40 years * Height \<150 cm * Weight \<60 kg * Body mass index ≥40 kg/m2 * Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection) * Chronic or pregnancy-induced hypertension * Hemoglobin \<10 gm/dL. * Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease * Polyhydramnios or known fetal abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total ephedrine dose | intraoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe hypotension | intraoperative | Severe hypotension: Systolic blood pressure \<70% of baseline |
| Time to the first ephedrine dose | intraoperative | — |
| Heart rate | intraoperative | — |
| Incidence of hypotension | intraoperative | Hypotension: Systolic blood pressure \<80% of baseline |
| Inferior vena cava collapsibility index | Baseline, at 1 and 5 minutes after intrathecal injection, delivery | Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter |
| Incidence of nausea and/or vomiting | intraoperative | — |
| Neonatal Apgar score | At 1 and 5 minutes after delivery | — |
| Inferior vena cava largest and smallest diameters | Baseline, at 1 and 5 minutes after intrathecal injection, delivery | — |
Countries
Egypt
Outcome results
None listed