Spinal Anesthesia Induced Hypotension During Cesarean Section

Study Overview
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Brief Summary
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The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Detailed Description
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Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Official Title
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Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section

Conditions
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Hypotension

Intervention / Treatment
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* Other: Colloid administration
* Other: Crystalloid administration
* Drug: phenylephrine infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II Elective cesarean section Weight 50-120 kg, Height 150-180 cm Normal singleton pregnancy Beyond 36 weeks gestation No known fetal abnormalities Ages 18-35 Exclusion Criteria: Contraindications to spinal anesthesia Multiple gestation, placenta previa, accreta Pregnancy induced hypertension or preeclampsia Diabetes mellitus, cardiovascular diseases Coagulopathy Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction Baseline HR <65 Failed spinal anesthesia/inadequate sensory block for surgery History of abnormal bleeding History of adverse reactions to hydroxyethylstarch

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colloid, then phenylephrine infusion<br>colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. | Other: Colloid administration<br>* The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.<br>Drug: phenylephrine infusion<br>* A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.<br>|
| Active Comparator: crystalloid, then phenylephrine infusion<br>crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. | Other: Crystalloid administration<br>* The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section.<br>Drug: phenylephrine infusion<br>* A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Maternal Hypotension |  | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of Phenylephrine Used |  | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby | 
| Incidence of Maternal Bradycardia |  | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby | 
| Fetal Cord Blood pH |  | delivery of the baby | 
| APGAR Scores | The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). | Apgar scores were assessed at 1 amd 5 min after delivery of the baby | 
| Incidence of Maternal Nausea and Vomiting |  | participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, cesarean section