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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194192
• Other study ID #: 810/2556(EC2)
• Secondary ID: (IO)R015731034
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: March 13, 2015
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural
• Hypotension

Intervention

Drug:
• Placebo
Normal saline 10 ml
• Ondansetron
Ondasetron 8 mg IV after spinal anesthesia
• Ephedrine
Ephedrine 10 mg IV after spinal anesthesia

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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

Outcome

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