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

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Hypotension Drug-Induced

Treatments: Drug: Ringer; Drug: Voluven

Study type: Interventional

Funder types: Other

Identifiers

NCT03465943

Hypotension in elective CS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ringer

Active Comparator group

Description:

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

Treatment:

Drug: Ringer

Voluven

Active Comparator group

Description:

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

Treatment:

Drug: Voluven

Drug: Ringer