Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery

Hypotension Clinical Trial

— NORA-CS  

Official title:

Influence of Diastolic Performance on the Response to Norepinephrine for Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery and Fetal Wellbeing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560634
• Other study ID #: 30865/19
• Status: Completed
• Start date: January 14, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Norepinephrine
Norepinephrine is administered as a continuous infusion at 0.05 mcg/kg/min and is kept to maintain systolic blood pressure within 90-120% of baseline during spinal anaesthesia. The infusion is started at the same time cerebrospinal fluid is obtained, immediately before injection of spinal medications, through a small-bore tubing connected directly to the peripheral intravenous catheter. It is stopped 5 minutes

Device:
• ClearSight®, Edwards Lifescience, Irvine, CA
All patients are connected to a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) by an inflatable finger cuff placed on the midphalanx of hand middle or ring finger with no radial artery catheter and its heart reference system (HRS) is zeroed at the level of the patient's midaxillary line. The ClearSight® monitoring is started in the pre-anaesthesia room and calibrated for 5 minutes before recording. The monitoring continues throughout the procedure until patient transfer in the recovery room. All data are anonymously collected on a USB pen for statistical analysis.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Policlinico Universitario Agostino Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indexed Cardiac Output	We aim to study if the diastolic performance of the heart measured by transthoracic echocardiography in healthy pregnant women at term undergoing spinal anesthesia for caesarean delivery influences the effects of norepinephrine on indexed cardiac output (CI) measured by non-invasive continuous hemodynamic monitoring.	Baseline/after spinal anesthesia/after delivery
Secondary	Indexed Stroke Volume	We will correlate diastolic performance measured by transthoracic echocardiography with the response to norepinephrine of indexed stroke volume (SVI) in ml, blood pressure (BP) in mmHg and heart rate (HR) in bpm measured by non-invasive continuous hemodynamic monitoring.	Baseline/after spinal anesthesia/after delivery
Secondary	Systolic Blood Pressure	We will correlate diastolic performance measured by transthoracic echocardiography with the response to norepinephrine of blood pressure (BP) in mmHg measured by non-invasive continuous hemodynamic monitoring.	Baseline/after spinal anesthesia/after delivery
Secondary	Heart Rate	We will correlate diastolic performance measured by transthoracic echocardiography with the response to norepinephrine of heart rate (HR) in bpm measured by non-invasive continuous hemodynamic monitoring.	Baseline/after spinal anesthesia/after delivery
Secondary	Apgar Scores	We ought to correlate the reduction of neonatal Apgar Scores with decreases of indexed cardiac output measured by non-invasive continuous hemodynamic monitoring.	Decreases of Indexed Cardiac Output after spinal anesthesia