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

Completed

• Conditions: Hypotension
• Interventions: Drug: Norepinephrine; Device: ClearSight®, Edwards Lifescience, Irvine, CA

• Registration Number: NCT04560634
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Diastolic Function	Norepinephrine	Diastolic Function within normal values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
Normal Diastolic Function	ClearSight®, Edwards Lifescience, Irvine, CA	Diastolic Function within normal values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
Impaired Diastolic Function	ClearSight®, Edwards Lifescience, Irvine, CA	Diastolic Function with pseudonormal pattern or impaired values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)
Impaired Diastolic Function	Norepinephrine	Diastolic Function with pseudonormal pattern or impaired values (defined in terms of E wave and A wave velocity and Deceleration Time according to the American Society of Echocardiography and the European Association of Echocardiography)

Primary Outcome Measures

Name	Time	Method
Indexed Cardiac Output	Baseline/after spinal anesthesia/after delivery	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.

Secondary Outcome Measures

Name	Time	Method
Indexed Stroke Volume	Baseline/after spinal anesthesia/after delivery	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.
Heart Rate	Baseline/after spinal anesthesia/after delivery	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.
Systolic Blood Pressure	Baseline/after spinal anesthesia/after delivery	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.
Apgar Scores	Decreases of Indexed Cardiac Output after spinal anesthesia	We ought to correlate the reduction of neonatal Apgar Scores with decreases of indexed cardiac output measured by non-invasive continuous hemodynamic monitoring.

Trial Locations

Locations (1)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy