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Trial record 14 of 535 for:    decongestants

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

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ClinicalTrials.gov Identifier: NCT03858465
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rafal Kowalczyk, Medical University of Warsaw

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Elderly Patients Spinal Anesthesia Lower Limb Surgery Drug: Ephedrine Drug: Phenylephrine Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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).
Drug: 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).
Drug: Phenylephrine
intravenous 0,3 mg of phenylephrine
Other Name: Phenylephrine Unimedic 10mg/ml




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. heart rate, expressed in bpm [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  2. 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.

  3. stroke volume, expressed in ml [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  4. cardiac index, expressed in L/min/m2, is the ratio of cardiac output to the body surface area. [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  5. stroke index, expressed in ml/m2, is the ratio of stroke volume to the body surface area. [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  6. systemic vascular resistance, expressed in Dynes.sec.cm⁻⁵ [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  7. 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 ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  8. stroke volume variation, expressed in percentage (%) [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  9. systemic oxygen delivery, expressed in ml/min [ Time Frame: 30 min ]
    parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.

  10. oxygen saturation, expressed in percentage (%) [ Time Frame: 30 min ]
    parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Rafał Kowalczyk, PhD +48604050654 mailto:raafau@op.pl
Contact: Nadzeya Abukhouskaya 533573961 nadzeya.abukhouskaya@gmail.com

Locations
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Poland
Infant Jesus Teaching Hospital Recruiting
Warsaw, Poland, 02-005
Contact: Rafał Kowalczyk, PhD    +48604050654    raafau@op.pl   
Contact: Nadzeya Abukhouskaya    +48533573961    nadzeya.abukhouskaya@gmail.com   
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Rafał Kowalczyk, PhD I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital

Publications:
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Responsible Party: Rafal Kowalczyk, Principal Investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03858465     History of Changes
Other Study ID Numbers: KB/129/2017
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Primary and secondary outcomes will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rafal Kowalczyk, Medical University of Warsaw:
Hypotension
Phenylephrine
Ephedryne

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Phenylephrine
Oxymetazoline
Pseudoephedrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents