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

NCT02194192 | Completed DMC

• 2 other identifiers: 810/2556(EC2)(IO)R015731034
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Keywords

prevention of hypotension; spinal anesthesia; cesarean section; ephedrine; ondansetron

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Maternal symptom: Nausea and vomiting after spinal anesthesia

  After spinal anesthesia until baby delivered

Other Outcomes (1)

• Apgar score

  one minute and five minute after delivery

Study Arms (3)

Group E

EXPERIMENTAL

Ephedrine 10 mg in Normal Saline 10 ml

Drug: Ephedrine

Group O

ACTIVE COMPARATOR

Ondansetron 8 mg in Normal saline 10 ml

Drug: Ondansetron

Group P

PLACEBO COMPARATOR

Normal saline 10 ml

Drug: Placebo

Interventions

Placebo DRUG

Normal saline 10 ml

Group P

Ondansetron DRUG

Ondasetron 8 mg IV after spinal anesthesia

Group O

Ephedrine DRUG

Ephedrine 10 mg IV after spinal anesthesia

Group E

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Elective cesarean section
• Patient accept spinal anesthesia
• ASA classification I-II
• Term, Singleton pregnancy
• Understand all process in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (5)

• 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.

  PMID: 22100822 BACKGROUND

• 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.

  PMID: 18675744 BACKGROUND

• 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.

  PMID: 12067872 BACKGROUND

• 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.

  PMID: 17054153 BACKGROUND

• 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.

  PMID: 14742392 BACKGROUND

MeSH Terms

Interventions

Ondansetron; Ephedrine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Patchareya Nivatpumin, M.D.

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

TH (1)