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Completed

NCT Number: NCT04560634

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

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.)

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age < 18 yo;
  • preeclampsia;
  • eclampsia;
  • atrial fibrillation and sinus tachycardia;
  • cardiovascular diseases;
  • neuromuscular disease;
  • emergent or urgent cesarean delivery;
  • coagulopathies;
  • contraindications to spinal anesthesia.

Treatment and study plan

norepinephrine

Drug

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

ClearSight®, Edwards Lifescience, Irvine, CA

Device

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.

Primary outcomes

  1. Indexed Cardiac Output

    Time frame: 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 outcomes

  1. Indexed Stroke Volume

    Time frame: 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.

  2. Systolic Blood Pressure

    Time frame: 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.

  3. Heart Rate

    Time frame: 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.

  4. Apgar Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: NORA-CS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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