Preloading to Prevent Hypotension During Cesarean Section

National Taiwan University

Status: Completed

Conditions: Obstetric Anesthesia Problems

Treatments: Procedure: Spinal anaesthesia; Drug: Fluid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03013140

201610025RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 20-45 y/o parturient
2. Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section

Exclusion criteria

1. Emergent C/S
2. BMI>35kg/m2
3. Height <150cm or >175 cm
4. Patients with major cardiovascular disease, preeclampsia or eclampsia.
5. Gestational age < 36wks
6. Multiple pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 2 patient groups

Goal-directed preloading

Experimental group

Description:

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%

Treatment:

Drug: Fluid therapy

Procedure: Spinal anaesthesia

Preloading

Active Comparator group

Description:

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

Treatment:

Procedure: Spinal anaesthesia