Clinical trial NCT04560634: Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery
Official title: Influence of Diastolic Performance on the Response to Norepinephrine for Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery and Fetal Wellbeing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Keywords: norepinephrine
Cesarean section
spinal anesthesia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women scheduled for elective C-section at our Institution willing to participate.

Brief summary: Background and rationale: The best agent to prevent spinal-induced hypotension is still uncertain but norepinephrine showed fewer effects on heart rate and cardiac output. In septic patients norepinephrine has been shown to produce an "endogenous fluid challenge".

Objective: We aim to assess if patients with impaired diastolic function (46% of pregnant women at term) are less able to maintain indexed cardiac output in response to norepinephrine infusion during spinal-induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.

Methods: We will assess by echocardiogram the diastolic function before surgery and will then start continuous non-invasive hemodynamic monitoring with a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) and perform a fluid challenge to relate diastolic disfunction with fluid responsiveness. Hemodynamic monitoring will continue throughout the surgery. Norepinephrine infusion will start concomitantly to beginning of spinal anesthesia and will stop 5 minutes after uterotonic medication.

Outcome: We aim to assess if patients with diastolic disfunction are less able to maintain cardiac output in response to norepinephrine infusion during spinal anesthesia induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.)


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. age \< 18 yo;
2. preeclampsia;
3. eclampsia;
4. atrial fibrillation and sinus tachycardia;
5. cardiovascular diseases;
6. neuromuscular disease;
7. emergent or urgent cesarean delivery;
8. coagulopathies;
9. contraindications to spinal anesthesia.

Primary outcomes:
measure: Indexed Cardiac Output
timeFrame: Baseline/after spinal anesthesia/after delivery
Secondary outcomes:
measure: Indexed Stroke Volume
timeFrame: Baseline/after spinal anesthesia/after delivery
measure: Systolic Blood Pressure
timeFrame: Baseline/after spinal anesthesia/after delivery
measure: Heart Rate
timeFrame: Baseline/after spinal anesthesia/after delivery
measure: Apgar Scores
timeFrame: Decreases of Indexed Cardiac Output after spinal anesthesia
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
References: