Ephedrine Versus Ondansetron During Cesarean Delivery

Study Overview
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Brief Summary
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More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death. The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.

Detailed Description
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Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery. Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.

Official Title
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Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial

Conditions
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Spinal Induced Hypotension

Intervention / Treatment
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* Drug: Ondansetron 4 MG
* Drug: Ondansetron 8mg
* Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution
* Other: 10 mL normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18, <40 years; American Society of Anesthesiologists physical status I or II; term pregnancy singleton pregnancy; elective cesarean delivery under spinal anesthesia Exclusion Criteria: Patients with a history of diabetes mellitus other than gestational diabetes, hypertension, body mass index >40 kg/m2, complicated pregnancy, allergy to study drugs, long QT syndrome, Contraindication to spinal anesthesia Patients who required general anesthesia were withdrawn from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used: Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E<br>Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. | Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution<br>* Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia<br>* Other names: Ephedrine group;|
| Experimental: Group OL<br>Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. | Drug: Ondansetron 4 MG<br>* Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia<br>* Other names: Low dose ondansetron group;|
| Experimental: Group OH<br>Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. | Drug: Ondansetron 8mg<br>* Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia<br>* Other names: Higher dose Ondanseteron group;|
| Placebo Comparator: Group P<br>Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo. Then under aseptic precautions, spinal anesthesia was administered. | Other: 10 mL normal saline<br>* 10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Maternal hypotension | Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min. | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score | 1and 5 min after fetal delivery | 5 min after fetal delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, Bezold-Jarisch reflex, ondansetron