Cardiac Index Changes With Ephedrine, Phenylephrine, Ondansetron and Norepinephrine During Spinal Anesthesia for Cesarian Section
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- cardiac output changes for 120 patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA I / II
- •Caesarean section, non-twinned
Exclusion Criteria
- •heart disease
- •non-gestational diabetes
- •pre-eclampsia
- •BMI greater than 40
- •contraindication to spinal anesthesia: patient refusal, medicinal allergy, long QT syndrome.
Arms & Interventions
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
Intervention: cardiac output changes with "ephedrine" (Drug)
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
Intervention: cardiac output changes with "phenylephrine" (Drug)
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
Intervention: cardiac output changes with "ondansetron" (Drug)
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
Intervention: cardiac output changes with "nor-epinephrine" (Drug)
Outcomes
Primary Outcomes
cardiac output changes for 120 patients
Time Frame: at time of delivery (right after spinal anesthesia until delivery)
In left lateral tilt position, cardiac output is calculated on the echocardiographic apical cut 5 cavities, every 5 minutes till delivery, with an infusion of either Ephedrine, Phenylephrine, Ondansetron or Norepinephrine. The cardiac output is calculated on the apical cut 5 cavities: Dc (cm3 / min) = ITV \* S \* HR Dc = cardiac output ITV (cm) = integral time velocity is measured by pulsed doppler at the level of the ascending aorta, on apical cut. Only the closing click (B2) is visible. If B2 is not visible, the sample is placed too much in the hunting chamber, which underestimates the ITV. If B1 and B2 are visible, the sample is too close to the aortic ring, which overestimates the ITV measurement. S = surface area of the aortic ring = (aorta diameter) ₂ \* π / 4 The diameter of the aorta is the average of three measurements at the beginning of systole, on the major axis.
Secondary Outcomes
- Maternal Blood Pressure(at time of delivery (right after spinal anesthesia until delivery))
- Nausea(at time of delivery (right after spinal anesthesia until delivery))
- heart rate(at time of delivery (right after spinal anesthesia until delivery))
- Vomiting(at time of delivery (right after spinal anesthesia until delivery))
- mean pH of the fetal cord blood(at time of delivery (right after spinal anesthesia until delivery))
Investigators
Ben marzouk Sofiene
MD, assistant professor
University Tunis El Manar