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

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2019-04-30

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.

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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.

Conditions

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Hypotension Drug-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ringer

This group will receive 1 L of Ringer's solution as a preload

Group Type ACTIVE_COMPARATOR

Ringer

Intervention Type DRUG

1L of Ringer's solution as a preload in one group.

Voluven

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

Group Type ACTIVE_COMPARATOR

Ringer

Intervention Type DRUG

1L of Ringer's solution as a preload in one group.

Voluven

Intervention Type DRUG

500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.

Interventions

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Ringer

1L of Ringer's solution as a preload in one group.

Intervention Type DRUG

Voluven

500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.

Intervention Type DRUG

Other Intervention Names

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Crystalloid Hydroxyethyl starch 6%

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes