Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery

Study Overview
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Brief Summary
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The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Levobupivacaine
* Drug: Phenylephrine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant woman scheduled for elective cesarean delivery under spinal anesthesia Exclusion Criteria: patients who refuse involved patients who have pre-eclampsia patients who have heart disease patients who fetal distress is suspicious

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUPI,P<br>patients who received hyperbaric bupivacaine and continous infusion of phenylephrine | Drug: Bupivacaine<br>* spinal anesthesia with hyperbaric bupivacaine<br>* Other names: Heavy bupivacaine;Drug: Phenylephrine<br>* continous infusion of phenylephrine<br>|
| Placebo Comparator: BUPI,N<br>patients who received hyperbaric bupivacaine and continous infusion of normal saline | Drug: Bupivacaine<br>* spinal anesthesia with hyperbaric bupivacaine<br>* Other names: Heavy bupivacaine;Drug: normal saline<br>* continous infusion of normal saline<br>|
| Experimental: LEVO,P<br>patients who received isobaric levobupivacaine and continous infusion of phenylephrine | Drug: Levobupivacaine<br>* spinal anesthesia with isobaric levobupivacaine<br>* Other names: chirocaine;Drug: Phenylephrine<br>* continous infusion of phenylephrine<br>|
| Active Comparator: LEVO,N<br>patients who received isobaric levobupivacaine and continous infusion of normal saline | Drug: Levobupivacaine<br>* spinal anesthesia with isobaric levobupivacaine<br>* Other names: chirocaine;Drug: normal saline<br>* continous infusion of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypotension events with treatment related | blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome. | during 30min after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of phenylephrine |  | during the surgery | 

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