Preloading to Prevent Hypotension During Cesarean Section

Study Overview
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Brief Summary
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Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.

Detailed Description
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Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.

Official Title
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Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section

Conditions
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Obstetric Anesthesia Problems

Intervention / Treatment
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* Drug: Fluid therapy
* Procedure: Spinal anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 20-45 y/o parturient Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section Exclusion criteria: Emergent C/S BMI>35kg/m2 Height <150cm or >175 cm Patients with major cardiovascular disease, preeclampsia or eclampsia. Gestational age < 36wks Multiple pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-directed preloading<br>Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat Ringer's Injection 3ml/kg within 3 minutes with 1-min gap until change in SV (ΔSV) <5% | Drug: Fluid therapy<br>* Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat Ringer's Injection 3ml/kg within 3 minutes with 1-min gap until ΔSV<5%<br>* Other names: Ringer's Injection;Procedure: Spinal anaesthesia<br>* Inject marcaine and fentanyl to CSF for anaesthesia<br>|
| Active Comparator: Preloading<br>Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml Ringer's injection with a pressurizer within 15 minutes. | Procedure: Spinal anaesthesia<br>* Inject marcaine and fentanyl to CSF for anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of maternal hypotension |  | delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of vasopressor |  | delivery | 
| Total fluid volume |  | delivery | 

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