Hypotension Drug-Induced, Hypotension During Surgery
Conditions
Brief summary
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.
Detailed 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.
Interventions
in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA; internal memory 60 gigabyte, 10 gigabyte used for operating system) with ClearSight non-invasive hemodynamic monitoring and with the Hypotension Prediction Index software enabled. They will not receive preventive vasopressors but only norepinephrine boluses if Hypotension Prediction Index \>85
DRUGNorepinephrine
Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Base excess | at birth | withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotensive episodes | from spinal anesthesia until delivery | (sistolic blood pressure \<80% of baseline values for \<1 minute) |
| Total vasopressor dose | from spinal anesthesia until delivery | total dose of micrograms administered during operation |
| Hypertensive episodes | from spinal anesthesia until delivery | systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>100 mmHg |
| Fetal arterial pH | at birth | value of fetal ph at the analisys from umbilical artery withdrown at birth |
| Apgar score | at 5 minutes from birth | Apgar is a quick test performed on a baby at 1 and 5 minutes after birth, examines the baby's breathing effort, heart rate, muscle tone, reflexes, skin color. Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. |
Contacts
Primary ContactChiara Sonnino, MD
Outcome results
None listed