Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Study Overview
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Brief Summary
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This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.

Detailed Description
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Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee. All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile. Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection. 10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr. Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5. The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.

Official Title
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Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.

Conditions
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Hypotension, Cesarean Section Complications

Intervention / Treatment
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* Drug: Norepinephrine bolus
* Device: cardiometry
* Drug: Norepinephrine infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I & II Non laboring Normotensive Elective cesarean delivery under spinal anesthesia. Baseline systolic blood pressure 90-140 mm Hg Exclusion Criteria: Known fetal abnormality. Preexisting or pregnancy-induced hypertension. Known cardiovascular or cerebrovascular disease. Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia. Weight <50 or >100 kg, height <140 or >180 cm. Inability or refusal to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: infusion<br>patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline | Device: cardiometry<br>* cardiac output, stroke volume and fluid responsiveness monitoring<br>Drug: Norepinephrine infusion<br>* 2.5 microgram/min infusion<br>|
| Active Comparator: bolus<br>patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value. | Drug: Norepinephrine bolus<br>* 5 microgram bolus therapy<br>Device: cardiometry<br>* cardiac output, stroke volume and fluid responsiveness monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| throracic volume variations change from baseline | using cardiometry | every 10 minutes up to 1 hour | 
| cardiac index change from baseline | using cardiometry | every 10 minutes up to 1 hour | 
| systemic vascular resistance change from baseline | using cardiometry | every 10 minutes up to 1 hour | 
| stroke volume variation change from baseline | using cardiometry | every 10 minutes and up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| umblical cord gases sample |  | in the first minute after delivery | 
| APGAR score | score from 1 to 10 with the highest score better for neonatal outcome | after 5 minutes and 10 minutes after delivery | 
| Non invasive MEAN blood pressure | change from baseline | every 10 minutes and up tp 1 hour | 
| Heart rate | change from baseline | every 10 minutes and up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypotension, norepinephrine