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Clinical Trials/NCT03013140
NCT03013140
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country71 target enrollmentFebruary 3, 2017

Overview

Phase
Not Applicable
Intervention
Fluid therapy
Conditions
Obstetric Anesthesia Problems
Sponsor
National Taiwan University Hospital
Enrollment
71
Locations
1
Primary Endpoint
Incidence of maternal hypotension
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2017
End Date
June 9, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Goal-directed preloading

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%

Intervention: Fluid therapy

Goal-directed preloading

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%

Intervention: Spinal anaesthesia

Preloading

Fluid therapy: Within 30 mins before spinal anaesthesia, infuse 1000ml "Ringer's injection" with a pressurizer within 15 minutes.

Intervention: Spinal anaesthesia

Outcomes

Primary Outcomes

Incidence of maternal hypotension

Time Frame: delivery

Secondary Outcomes

  • Dosage of vasopressor(delivery)
  • Total fluid volume(delivery)

Study Sites (1)

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