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Preloading to Prevent Hypotension During Cesarean Section

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03013140
Enrollment
71
Registered
2017-01-06
Start date
2017-02-03
Completion date
2019-06-09
Last updated
2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Anesthesia Problems

Keywords

Anesthesia, Obstetric, fluid therapy, cesarean section, spinal anesthesia

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.

Interventions

DRUGFluid therapy

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%

PROCEDURESpinal anaesthesia

Inject marcaine and fentanyl to CSF for anaesthesia

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence of maternal hypotensiondelivery

Secondary

MeasureTime frame
Total fluid volumedelivery
Dosage of vasopressordelivery

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026