The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Intervention / Treatment
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* Other: Colloid Preload
* Other: colloid co-load
* Other: Crystalloid preload
* Other: Crystalloid Co-load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant 37-41 weeks one fetus scheduled for C/S under spinal anesthesia accepting to participate Exclusion Criteria: Emergency surgery placenta previa preeclampsia 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colloid preload<br>20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia. | Other: Colloid Preload<br>* preload infusion<br>* Other names: Gelofusin;|
| Active Comparator: Colloid Co-load<br>20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia. | Other: colloid co-load<br>* co-load infusion<br>* Other names: gelofusin;|
| Active Comparator: Crystalloid Preload<br>20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia. | Other: Crystalloid preload<br>* preload infusion<br>* Other names: Ringers lactate solution;|
| Active Comparator: Crystalloid Co-load<br>20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia. | Other: Crystalloid Co-load<br>* co-load infusion<br>* Other names: Ringers lactate solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores | Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed. | Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end. |