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

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT02194192

Collaborator

(none)

168

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Adverse Effect, Spinal and Epidural	Drug: Placebo Drug: Ondansetron Drug: Ephedrine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group E Ephedrine 10 mg in Normal Saline 10 ml	Drug: Ephedrine Ephedrine 10 mg IV after spinal anesthesia
Active Comparator: Group O Ondansetron 8 mg in Normal saline 10 ml	Drug: Ondansetron Ondasetron 8 mg IV after spinal anesthesia
Placebo Comparator: Group P Normal saline 10 ml	Drug: Placebo Normal saline 10 ml

Arm

Intervention/Treatment

Experimental: Group E

Ephedrine 10 mg in Normal Saline 10 ml

Drug: Ephedrine

Ephedrine 10 mg IV after spinal anesthesia

Active Comparator: Group O

Ondansetron 8 mg in Normal saline 10 ml

Drug: Ondansetron

Ondasetron 8 mg IV after spinal anesthesia

Placebo Comparator: Group P

Normal saline 10 ml

Drug: Placebo

Normal saline 10 ml

Outcome Measures

Primary Outcome Measures

Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension. [After spinal block to until baby delivered]
Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.