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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

the outcome accessor and care provider will be aware in which gropu the patient was

Study Groups

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Colloid preload

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Colloid Preload

Intervention Type OTHER

preload infusion

Colloid Co-load

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.

Group Type ACTIVE_COMPARATOR

colloid co-load

Intervention Type OTHER

co-load infusion

Crystalloid Preload

20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Crystalloid preload

Intervention Type OTHER

preload infusion

Crystalloid Co-load

20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Crystalloid Co-load

Intervention Type OTHER

co-load infusion

Interventions

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Colloid Preload

preload infusion

Intervention Type OTHER

colloid co-load

co-load infusion

Intervention Type OTHER

Crystalloid preload

preload infusion

Intervention Type OTHER

Crystalloid Co-load

co-load infusion

Intervention Type OTHER

Other Intervention Names

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Gelofusin gelofusin Ringers lactate solution Ringers lactate solution

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes