Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypotension Drug-Induced; Hypotension During Surgery

Treatments: Drug: Norepinephrine; Device: Hypotension Prediction Index

Study type: Interventional

Funder types: Other

Identifiers

NCT05970770

HPI vs NIBP

Details and patient eligibility

About

The goal of this randomized controlled trial is to compare for non inferiority for fetal wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.

The main question it aims to answer are:

• are fetal arterial base excess comparable with the two treatments?

Participants will undergo continuous noninvasive hemodynamic monitoring with advanced Hypotension Prediction Index Researchers will compare with patients receiving continuous norepinephrine infusion and standard blood pressure monitoring with arm cuff.

Full description

In the Hypotension Prediction Index group, patients will be monitored continuously with a noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al algorithm that predicts impeding hypotension if it is greater than 85. In the treatment group, patients will be treated with norepinephrine boluses if the Hypotension Prediction Index is >85. In the control group patients will be treated with preventive continuous infusion of norepinephrine and blood pressure will be measured noninvasively every minute. Data about blood pressure and the vasopressive treatment will start concomitantly to the administration of spinal anesthesia and will stop after delivery. blood gas samples will be then collected from the placental umbilical artery to compare fetal arterial base excess as primary outcome for non-inferiority.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.

Exclusion criteria

• preeclampsia;
• eclampsia;
• atrial fibrillation and sinus tachycardia;
• cardiovascular diseases;
• neuromuscular disease;
• emergent or urgent cesarean delivery;
• coagulopathies;
• contraindications to spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Hypotension Prediction Index

Experimental group

Description:

Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine

Treatment:

Drug: Norepinephrine

Device: Hypotension Prediction Index

Non Invasive Blood Pressure

Active Comparator group

Description:

Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute

Treatment:

Drug: Norepinephrine