- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03858465
Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly (HypoGer)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rafał Kowalczyk, PhD
- Phone Number: +48604050654
- Email: mailto:raafau@op.pl
Study Contact Backup
- Name: Nadzeya Abukhouskaya
- Phone Number: 533573961
- Email: nadzeya.abukhouskaya@gmail.com
Study Locations
-
-
-
Warsaw, Poland, 02-005
- Infant Jesus Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
intravenous 25 mg of ephedrine
Other Names:
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate, expressed in bpm
Time Frame: 30 min
|
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
|
30 min
|
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.
|
30 min
|
stroke volume, expressed in ml
Time Frame: 30 min
|
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.
Time Frame: 30 min
|
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.
Time Frame: 30 min
|
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
Time Frame: 30 min
|
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.
Time Frame: 30 min
|
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
|
30 min
|
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.
|
30 min
|
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.
|
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.
|
30 min
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Fractures, Bone
- Wounds and Injuries
- Leg Injuries
- Femoral Fractures
- Hip Injuries
- Hip Fractures
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Ephedrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- KB/129/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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