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Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia; Adverse Effect, Spinal and Epidural

Intervention: Placebo (Drug); Ondansetron (Drug); Ephedrine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Patchareya Nivatpumin, M.D., Principal Investigator, Affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

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.

Clinical Details

Official title: Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.

Secondary outcome: Maternal symptom: Nausea and vomiting after spinal anesthesia

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information

Related publications:

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.

Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszułowicz 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.

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.

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.

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.

Starting date: July 2014
Last updated: March 13, 2015

Page last updated: August 23, 2015

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