Anesthesia; Adverse Effect, Spinal and Epidural
Conditions
Keywords
prevention of hypotension, spinal anesthesia, cesarean section, ephedrine, ondansetron
Brief summary
Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis. Many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex. This aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.
Interventions
DRUGPlacebo
Normal saline 10 ml
DRUGOndansetron
Ondasetron 8 mg IV after spinal anesthesia
DRUGEphedrine
Ephedrine 10 mg IV after spinal anesthesia
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 years * Elective cesarean section * Patient accept spinal anesthesia * ASA classification I-II * Term, Singleton pregnancy * Understand all process in this study
Exclusion criteria
* DM any type that not the gestational DM * Hypertensive disorder * BMI\>40 * Complicated pregnancy such as placenta previa, preeclampsia * Allergic to study drugs * Long QT syndrome * Contraindication to spinal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension. | After spinal block to until baby delivered | Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery. |
Secondary
| Measure | Time frame |
|---|---|
| Maternal symptom: Nausea and vomiting after spinal anesthesia | After spinal anesthesia until baby delivered |
Other
| Measure | Time frame |
|---|---|
| Apgar score | one minute and five minute after delivery |
Countries
Thailand
Outcome results
None listed