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

Early Phase 1

• Conditions: Hypotension Drug-Induced
• Interventions: Drug: Ringer; Drug: Voluven

• Registration Number: NCT03465943
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-03-08
• Last Update Submitted: 2018-03-08
• Study First Posted: 2018-03-15
• Last Update Posted: 2018-03-15
• Primary Completion: 2019-03
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Age : 18-40 years
• ASA 1&2

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voluven	Ringer	This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Ringer	Ringer	This group will receive 1 L of Ringer's solution as a preload
Voluven	Voluven	This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	1 hour	Decrease in systolic blood pressure more than 20% of base line

Secondary Outcome Measures

Name	Time	Method
Perfusion index	1 hour	Derived from pulse oximeter
Urine output	1 hour
Heart rate	1 hour