Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

Study Overview
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Brief Summary
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The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section. To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.

Detailed Description
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Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world. One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ). This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them. Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space. Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.

Official Title
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Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia

Conditions
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Hypotension Drug-Induced

Intervention / Treatment
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* Drug: Ringer
* Drug: Voluven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : 18-40 years ASA 1&2 Exclusion Criteria: Patients with morbid obesity. Pre-existing or pregnancy-induced hypertension. Known cardiovascular or cerebrovascular disease. Abnormal CTG tracing. Any other contraindications for intrathecal anaesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ringer<br>This group will receive 1 L of Ringer's solution as a preload | Drug: Ringer<br>* 1L of Ringer's solution as a preload in one group.<br>* Other names: Crystalloid;|
| Active Comparator: Voluven<br>This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload | Drug: Ringer<br>* 1L of Ringer's solution as a preload in one group.<br>* Other names: Crystalloid;Drug: Voluven<br>* 500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.<br>* Other names: Hydroxyethyl starch 6%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | Decrease in systolic blood pressure more than 20% of base line | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion index | Derived from pulse oximeter | 1 hour | 
| Heart rate |  | 1 hour | 
| Urine output |  | 1 hour |