Anesthesia; Adverse Effect, Spinal and Epidural Clinical Trial
Official title:
Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial
Verified date | March 2015 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 168 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. Review. — View Citation
Lee A, Ngan Kee WD, Gin T. A dose-response meta-analysis of prophylactic intravenous ephedrine for the prevention of hypotension during spinal anesthesia for elective cesarean delivery. Anesth Analg. 2004 Feb;98(2):483-90, table of contents. Erratum in: Anesth Analg. 2004 Apr;98(4):955. — View Citation
Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. — View Citation
Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010. — View Citation
Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Apgar score | one minute and five minute after delivery | Yes | |
Primary | Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension. | Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery. | After spinal block to until baby delivered | Yes |
Secondary | Maternal symptom: Nausea and vomiting after spinal anesthesia | After spinal anesthesia until baby delivered | Yes |
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