Ondansetron for Postspinal Anesthesia Hypotension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Detailed Description
-----------------
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

Official Title
-----------------
Ondansetron for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial

Conditions
-----------------
Adverse Effect

Intervention / Treatment
-----------------
* Drug: normal saline
* Drug: Ondansetron 4 mg
* Drug: Ondansetron 8 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-40 years Primipara or multipara Singleton pregnancy ≥ 37 weeks American Society of Anesthesiologists physical status classification I to II Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: Body height < 150 cm Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2 Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg Hemoglobin < 7g/dl Fetal distress, or known fetal developmental anomaly

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia. | Drug: normal saline<br>* A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.<br>* Other names: NS;|
| Experimental: Ondansetron 4 mg<br>A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia. | Drug: Ondansetron 4 mg<br>* A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.<br>* Other names: 5-HT3 receptor antagonist;|
| Experimental: Ondansetron 8 mg<br>A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia. | Drug: Ondansetron 8 mg<br>* A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.<br>* Other names: 5-HT3 receptor antagonist;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall stability of systolic blood pressure control versus baseline | Evaluated by performance error (PE) | 1-15 minutes after spinal anesthesia | 
| The incidence of post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 80% of the baseline | 1-15 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall stability of heart rate control versus baseline | Evaluated by performance error (PE). | 1-15 minutes after spinal anesthesia | 
| The incidence of severe post-spinal anesthesia hypotension | Systolic blood pressure (SBP) < 60% of the baseline | 1-15 minutes after spinal anesthesia | 
| The incidence of nausea and vomiting. | Presence of nausea and vomiting in patients after spinal anesthesia | 1-15 minutes after spinal anesthesia | 
| The incidence of bradycardia. | Heart rate < 55 beats/min. | 1-15 minutes after spinal anesthesia | 
| The incidence of hypertension | Systolic blood pressure (SBP) >120% of the baseline. | 1-15 minutes after spinal anesthesia | 
| pH | From umbilical arterial blood gases. | Immediately after delivery | 
| Partial pressure of oxygen | From umbilical arterial blood gases. | Immediately after delivery | 
| Base excess | From umbilical arterial blood gases. | Immediately after delivery | 
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 1 min after delivery | 
| APGAR score | A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration | 5 min after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ondansetron, Coload, Hypotension, Cesarean section