Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

Study Overview
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Brief Summary
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Spinal anesthesia is often used for lower limb surgery in elderly. Hypotension is a side effect of spinal block. In this study, intravenous ephedrine and phenylephrine will be compared with each other to prevent spinal anesthesia-induced hypotension, which is defined in absolute terms as a systolic blood pressure < 100 mmHg or in relative terms as a 20% fall of systolic blood pressure from baseline.

Detailed Description
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Randomized single centre clinical randomized study will be performed on 50 participants. The inclusion criteria are participants (age more than 65 years) with proximal femoral fracture scheduled for lower limb surgery under spinal anesthesia. The Ethics Committee approved this prospective study. Informed consent will be taken from individual subjects. Participants are randomly allocated into one of the two study groups. Group A: participants who will receive intravenous 25 mg of ephedrine added to syringe with 50 ml 0,9% sodium chloride solution during 20 minutes. Group B: Phenylephrine 5 mg will be added to syringe with 50 ml 0,9% sodium chloride solution, participants will receive intravenous 0,3 mg of phenylephrine during 20 minutes. Randomization is achieved with the help of Random.org. In order to reduce pain prior to spinal anesthesia an ultrasound-guided fascia iliaca block will be performed using a volume of 30 ml ropivacaine 0,2%. After skin infiltration with 3 ml of lidocaine, a 25G Pencan spinal needle will be inserted at the L3-L4 or L4-L5 vertebral interspaces. After aspirating cerebrospinal fluid, participants will receive hyperbaric bupivacaine 0.5% at 0,11 mg/cm according to the participant height. Ephedrine and phenylephrine will be given intravenous immediately after injection of bupivacaine. Impedance cardiography will be used to measure hemodynamic parameters: cardiac output, stroke volume, cardiac index, stroke index, systemic vascular resistance, systemic vascular resistance index. Heart rate, blood pressure and oxygen saturation will also be controlled. All these parameters will be measured and recorded every 5 minutes until 30 minutes after spinal anesthesia. The data will be statistically analyzed.

Official Title
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Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

Conditions
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Hip Fractures, Elderly Patients, Spinal Anesthesia, Lower Limb Surgery

Intervention / Treatment
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* Drug: Ephedrine
* Drug: Phenylephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elderly (age more than 65 years) hip fracture scheduled for lower limb surgery under spinal anesthesia spinal anesthesia Exclusion Criteria: contraindications to spinal anesthesia participant refusal age less than 65 bradycardia (heart rate less than 60) participants unable to give consent or inability to communicate

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25 mg of ephedrine<br>participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine). | Drug: Ephedrine<br>* intravenous 25 mg of ephedrine<br>* Other names: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml;|
| Active Comparator: 0,3 mg of phenylephrine<br>participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine). | Drug: Phenylephrine<br>* intravenous 0,3 mg of phenylephrine<br>* Other names: Phenylephrine Unimedic 10mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood preasure (mean arterial pressure, systolic and diastolic blood pressure) | parameter will be measured and recorded every 5 min after spinal anesthesia. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate, expressed in bpm | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| cardiac output, expressed in L/min | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| stroke volume, expressed in ml | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area. | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area. | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| systemic vascular resistance, expressed in Dynes.sec.cm-⁵ | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| systemic vascular resistance index, expressed in Dynes.sec.cm-⁵/m2, is the ratio of systemic vascular resistance to the body surface area. | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| stroke volume variation, expressed in percentage (%) | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| systemic oxygen delivery, expressed in ml/min | parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia. | 30 min | 
| oxygen saturation, expressed in percentage (%) | parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia. | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ephedryne, Hypotension, Phenylephrine