Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia

NCT ID: NCT03421860

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2018-03-30

Brief Summary

The purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery.

For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study includes 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of four groups.

Detailed Description

This study will be a prospective, randomized, double-blind controlled trial. After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 4 treatment groups prior to cesarean delivery.

Group A: 9 mg of ephedrine Group B: 100 mcg of phenylephrine Group C: 8 mg of ondansetron Group D: 0,25 mcg/kg of norepinephrine Baseline arterial blood pressure and heart rate will be measured in the left lateral tilt position, before anesthesia and then every minute.The cardiac output is calculated on the apical cut 5 cavities, before anesthesia and then every 5 miutes. No fluid preloading will be administered till delivery.

The primary endpoint is cardiac output changes in each groups. The secondary endpoint is the number of provider interventions needed to maintain the SBP within 80-120% of baseline for each groups.

Bradycardia (HR less than 50 BPM) will be treated with 1 mg of Atropine. Hypotension ( decrease of more than 20% of the baseline value or a PAS <90 mm Hg) will be treated with 6 mg of ephedrine, without any fluid loading.

The spinal anesthesia will be carried out in a seated position, level L3-L4 or L4-L5 with a slow injection over 30 seconds of a mixture of 10 mg of 0.5% Bupivacaine with 5 mcg of Sufentanil. The hot / cold test to determine the block level is required. A spinal anesthesia is validated if the cold test reaches the T4 level. The 10 ml syringe will be administered immediately after spinal anesthesia. The patient will be placed in the left lateral tilt position of 15¤, then put back into strict DD immediately after the delivery. Cardiovascular parameters (PAS, PAM, PAD, HR) will be recorded every minute until delivery. Echocardiographic measurement of cardiac output will be recorded every five minutes until delivery.

Measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, cardiac output, incidence of nausea and vomiting (NV), incidence of arrhythmia and fetal cord blood analysis (pH) at delivery.

Conditions

Cardiac Output, Low

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ephedrine

will receive ephedrine :a bolus of 9 mg after SA once intervention: will receive complementary doses of ephedrine 6 mgto maintain systolic blood pressure above 80 % of baseline

Group Type: ACTIVE_COMPARATOR

cardiac output changes with "ephedrine"

Intervention Type: DRUG

measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

phenylephrine

will receive Phenylephrine : a bolus of 100 mcg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Group Type: ACTIVE_COMPARATOR

cardiac output changes with "phenylephrine"

Intervention Type: DRUG

measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

ondansetron

will receive ondansetron: a bolus of 8 mg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Group Type: ACTIVE_COMPARATOR

cardiac output changes with "ondansetron"

Intervention Type: DRUG

measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

norepinephrine

will receive noradrenaline (norepinephrine) a bolus of 0,25 mcg/kg once intervention: will receive complementary doses of ephedrine 6 mg to maintain systolic blood pressure above 80 % of baseline

Group Type: ACTIVE_COMPARATOR

cardiac output changes with "nor-epinephrine"

Intervention Type: DRUG

measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Interventions

cardiac output changes with "ephedrine"

measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Intervention Type: DRUG

cardiac output changes with "phenylephrine"

measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Intervention Type: DRUG

cardiac output changes with "ondansetron"

measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Intervention Type: DRUG

cardiac output changes with "nor-epinephrine"

measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline

Intervention Type: DRUG

Other Intervention Names

cardiac output: CO (cm3 / min) = ITV * S * HR . ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.; cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.; cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.; cardiac output: CO (cm3 / min) = ITV * S * HR. ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut.

Eligibility Criteria

Inclusion Criteria

• ASA I / II
• Caesarean section, non-twinned

Exclusion Criteria

• heart disease
• HTA
• non-gestational diabetes
• pre-eclampsia
• sepsis
• BMI greater than 40
• contraindication to spinal anesthesia: patient refusal, medicinal allergy, long QT syndrome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ben marzouk Sofiene

MD, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hayen maghrebi, professor

Role: STUDY_CHAIR

tunis maternity center

Locations

Tunis maternity and neonatology center, minisetry of public health

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

bich-fel

Identifier Type: -

Identifier Source: org_study_id