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

NCT ID: NCT04560634

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-12-15

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Norepinephrine

Intervention Type: 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

Intervention Type: 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

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)

Norepinephrine

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

SONNINO CHIARA

Registered Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Countries

Italy

Other Identifiers

30865/19

Identifier Type: -

Identifier Source: org_study_id