Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities

Parc de Salut Mar120 enrolled

Overview

The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an absolute value \<90-100 mmHg, he presents an incident of 80-85% after an anesthesia intradural in the pregnant women, fact that worries for provoking undesirable effects so much in the mother and as in the fetus /newborn baby. The purpose of this study is to determine the effectiveness of intermittent pneumatic compression system in the lower extremities in order to reduce the vasopressors drugs requirements to maintain hemodynamic stability in pregnant women undergoing elective caesarean sections with an spinal anaesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Hypotension

Interventions

Elective caesarean section under spinal anaesthesia.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed. Exclusion Criteria: * Caesarean section urgent / emergent * Caesarean section with epidural anaesthesia * Caesarean section of multiple pregnancies * Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (\<32 weeks) * Valvular heart disease and / or ischemic * High blood pressure diagnosed and in treatment. * Sepsis * Morbid obesity (BMI\> 40) * Insulin-dependent diabetes * Block level achieved with spinal anaesthesia\> T5 * Patients that can not meet the study protocol

Locations (3)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron Hospital

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

The dose of needed vasopressor (phenylephrine).

Time frame: From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery.

Secondary Outcomes

Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine).

Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension.

Time frame: From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours).