Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly (HypoGer)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03858465|
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures Elderly Patients Spinal Anesthesia Lower Limb Surgery||Drug: Ephedrine Drug: Phenylephrine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||February 24, 2019|
|Estimated Study Completion Date :||April 1, 2020|
Active Comparator: 25 mg of ephedrine
participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine).
intravenous 25 mg of ephedrine
Other Name: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml
Active Comparator: 0,3 mg of phenylephrine
participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine).
intravenous 0,3 mg of phenylephrine
Other Name: Phenylephrine Unimedic 10mg/ml
- blood preasure (mean arterial pressure, systolic and diastolic blood pressure) [ Time Frame: 30 min ]parameter will be measured and recorded every 5 min after spinal anesthesia.
- heart rate, expressed in bpm [ Time Frame: 30 min ]parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
- cardiac output, expressed in L/min [ Time Frame: 30 min ]parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
- stroke volume, expressed in ml [ Time Frame: 30 min ]parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
- cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area. [ Time Frame: 30 min ]
- stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area. [ Time Frame: 30 min ]
- systemic vascular resistance, expressed in Dynes.sec.cm-⁵ [ Time Frame: 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. [ Time Frame: 30 min ]
- stroke volume variation, expressed in percentage (%) [ Time Frame: 30 min ]
- systemic oxygen delivery, expressed in ml/min [ Time Frame: 30 min ]
- oxygen saturation, expressed in percentage (%) [ Time Frame: 30 min ]parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858465
|Contact: Rafał Kowalczyk, PhD||+48604050654||mailto:email@example.com|
|Contact: Nadzeya Abukhouskayafirstname.lastname@example.org|
|Principal Investigator:||Rafał Kowalczyk, PhD||I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital|