The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section
This trial is active, not recruiting.
|Condition||complications; anesthesia, spinal and epidural, in pregnancy|
|Treatments||colloid preload, colloid co-load, crystalloid preload, crystalloid co-load|
|Start date||April 2014|
|End date||August 2016|
|Trial size||80 participants|
|Trial identifier||NCT02680678, BAU|
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
time frame: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.
Female participants from 18 years up to 50 years old.
- pregnant 37-41 weeks
- one fetus
- scheduled for C/S under spinal anesthesia
- accepting to participate
- Emergency surgery
- placenta previa
- cardiovascular and cerebrovascular comorbidities
- morbid obesity (BMI>40)
- pregnancy weeks <36 and > 41
- The use of vasoconstrictors
- Severe Anemia ( Hb <9 g/dl)
- Refusal or known contraindication for spinal anesthesia
|Official title||Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index|
|Principal investigator||Hafize Fisun Demir|
|Description||To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.|
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