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

Primary Purpose

Anesthesia; Adverse Effect, Spinal and Epidural

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Placebo
Ondansetron
Ephedrine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia; Adverse Effect, Spinal and Epidural focused on measuring prevention of hypotension, spinal anesthesia, cesarean section, ephedrine, ondansetron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group E

Group O

Group P

Arm Description

Ephedrine 10 mg in Normal Saline 10 ml

Ondansetron 8 mg in Normal saline 10 ml

Normal saline 10 ml

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maternal symptom: Nausea and vomiting after spinal anesthesia

Full Information

First Posted
July 16, 2014
Last Updated
March 13, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02194192
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Spinal and Epidural
Keywords
prevention of hypotension, spinal anesthesia, cesarean section, ephedrine, ondansetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group E
Arm Type
Experimental
Arm Description
Ephedrine 10 mg in Normal Saline 10 ml
Arm Title
Group O
Arm Type
Active Comparator
Arm Description
Ondansetron 8 mg in Normal saline 10 ml
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Normal saline 10 ml
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline 10 ml
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Ondasetron 8 mg IV after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Intervention Description
Ephedrine 10 mg IV after spinal anesthesia
Primary Outcome Measure Information:
Title
Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
Description
Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.
Time Frame
After spinal block to until baby delivered
Secondary Outcome Measure Information:
Title
Maternal symptom: Nausea and vomiting after spinal anesthesia
Time Frame
After spinal anesthesia until baby delivered
Other Pre-specified Outcome Measures:
Title
Apgar score
Time Frame
one minute and five minute after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patchareya Nivatpumin, M.D.
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22100822
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.
Results Reference
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PubMed Identifier
18675744
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.
Results Reference
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PubMed Identifier
12067872
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.
Results Reference
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PubMed Identifier
17054153
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.
Results Reference
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PubMed Identifier
14742392
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. Erratum In: Anesth Analg. 2004 Apr;98(4):955.
Results Reference
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Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

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