Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
Overview
- Phase
- Early Phase 1
- Intervention
- Ringer
- Conditions
- Hypotension Drug-Induced
- Sponsor
- Assiut University
- Enrollment
- 60
- Primary Endpoint
- Incidence of hypotension
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Rafeek Ramez Shawky Aziz
Principal Investigator
Assiut University
Eligibility Criteria
Inclusion Criteria
- •Age : 18-40 years
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.
Arms & Interventions
Voluven
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Intervention: Ringer
Ringer
This group will receive 1 L of Ringer's solution as a preload
Intervention: Ringer
Voluven
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Intervention: Voluven
Outcomes
Primary Outcomes
Incidence of hypotension
Time Frame: 1 hour
Decrease in systolic blood pressure more than 20% of base line
Secondary Outcomes
- Heart rate(1 hour)
- Perfusion index(1 hour)
- Urine output(1 hour)