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

NCT04560634 | Completed DMC FDA Device

• 1 other identifier: 30865/19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.)

Conditions

Hypotension

Keywords

norepinephrine; Cesarean section; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Indexed Stroke Volume

  Baseline/after spinal anesthesia/after delivery

• Systolic Blood Pressure

  Baseline/after spinal anesthesia/after delivery

• Heart Rate

  Baseline/after spinal anesthesia/after delivery

• Apgar Scores

  Decreases of Indexed Cardiac Output after spinal anesthesia

Study Arms (2)

Normal Diastolic Function

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)

Drug: Norepinephrine; Device: ClearSight®, Edwards Lifescience, Irvine, CA

Impaired Diastolic Function

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)

Drug: Norepinephrine; Device: ClearSight®, Edwards Lifescience, Irvine, CA

Interventions

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

Impaired Diastolic Function; Normal Diastolic Function

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.

Impaired Diastolic Function; Normal Diastolic Function

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: this study only enrolls pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women scheduled for elective C-section at our Institution willing to participate.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Anesthesiologist

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 23, 2020
• Study Start: January 14, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

IT (1)