Infant Jesus Teaching Hospital
Warsaw, 02-005, Poland
NCT Number: NCT03858465
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Warsaw, 02-005, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous 25 mg of ephedrine
Other names: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml
intravenous 0,3 mg of phenylephrine
Other names: Phenylephrine Unimedic 10mg/ml
Time frame: 30 min
parameter will be measured and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Time frame: 30 min
parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.
Medical University of Warsaw
Other
Acronym: HypoGer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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