Clinical trial NCT02194192: Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section
Official title: Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
Keywords: prevention of hypotension
spinal anesthesia
cesarean section
ephedrine
ondansetron
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
timeFrame: After spinal block to until baby delivered
Secondary outcomes:
measure: Maternal symptom: Nausea and vomiting after spinal anesthesia
timeFrame: After spinal anesthesia until baby delivered
Other outcomes:
measure: Apgar score
timeFrame: one minute and five minute after delivery
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.1007/BF03017387.
citation: 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. doi: 10.1002/14651858.CD002251.pub2.
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):483-490. doi: 10.1213/01.ANE.0000096183.49619.FC.