Hip FracturesHypoGerNCT03858465
Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly
A study testing Ephedrine and Phenylephrine in people with Hip Fractures and Elderly Patients, run by Medical University of Warsaw at 1 site in Poland.
Trial 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 <… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Elderly Patients, Spinal Anesthesia
- What is being tested?
- Ephedrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2019to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly (age more than 65 years)
- hip fracture scheduled for lower limb surgery under spinal anesthesia
- spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Fractures, Elderly Patients, Spinal Anesthesia, Lower Limb Surgery
- Being tested
- Ephedrine, Phenylephrine
- Keywords
- Hypotension, Phenylephrine, Ephedryne
- Medical subject headings
- Hip Fractures, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/ml
intravenous 25 mg of ephedrine
PhenylephrineDrug
Also called Phenylephrine Unimedic 10mg/ml
intravenous 0,3 mg of phenylephrine
| Study group | Role | What they receive |
|---|---|---|
| 25 mg of ephedrine | Active comparator | participants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine). Receives: Drug: Ephedrine |
| 0,3 mg of phenylephrine | Active comparator | participants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine). Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood preasure (mean arterial pressure, systolic and diastolic blood pressure)
parameter will be measured and recorded every 5 min after spinal anesthesia.
Measured: 30 min
Secondary outcomes (10)
heart rate, expressed in bpm
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Measured: 30 min
cardiac output, expressed in L/min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Measured: 30 min
stroke volume, expressed in ml
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 min
stroke volume variation, expressed in percentage (%)
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Measured: 30 min
systemic oxygen delivery, expressed in ml/min
parameter will be measured using impedance cardiography and recorded every 5 min after spinal anesthesia.
Measured: 30 min
oxygen saturation, expressed in percentage (%)
parameter will be measured using pulse oximetry and recorded every 5 min after spinal anesthesia.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Feb 2019
- Primary completion24 Feb 2019
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafal Kowalczyk, Medical University of Warsaw
- Investigators
- Rafał Kowalczyk, PhD, Principal investigator, I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858465
- Sponsor's protocol ID
- KB/129/2017
- Acronym
- HypoGer
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Primary and secondary outcomes will be available
Publications
Abbasivash R, Sane S, Golmohammadi M, Shokuhi S, Toosi FD. Comparing prophylactic effect of phenylephrine and ephedrine on hypotension during spinal anesthesia for hip fracture surgery. Adv Biomed Res. 2016 Oct 26;5:167. doi: 10.4103/2277-9175.190943. eCollection 2016.
PubMed 27995106
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly
- ClinicalTrials.gov ID
- NCT03858465
- Acronym / sponsor ID
- HypoGer / KB/129/2017
- Conditions
- Hip Fractures, Elderly Patients, Spinal Anesthesia, Lower Limb Surgery
- Keywords
- Hypotension, Phenylephrine, Ephedryne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 24 Feb 2019 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mg of ephedrine | Active comparator | Drug: Ephedrineparticipants who will receive intravenous 1,25mg/min ephedrine during 20 minutes (total dosage is 25 mg of ephedrine). |
| 0,3 mg of phenylephrine | Active comparator | Drug: Phenylephrineparticipants who will receive intravenous 0,015mg/min phenylephrine during 20 minutes (total dosage is 0,3mg of phenylephrine). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- elderly (age more than 65 years)
- hip fracture scheduled for lower limb surgery under spinal anesthesia
- spinal anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EphedrineAlso: Ephedrinum hydrochloricum WZF Polfa Warszawa 25mg/mlintravenous 25 mg of ephedrine | Drug | 25 mg of ephedrine |
| PhenylephrineAlso: Phenylephrine Unimedic 10mg/mlintravenous 0,3 mg of phenylephrine | Drug | 0,3 mg of phenylephrine |
Primary outcome
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.
10 secondary outcomes
heart rate, expressed in bpm
Time frame: 30 min
cardiac output, expressed in L/min
Time frame: 30 min
stroke volume, expressed in ml
Time frame: 30 min
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 27995106Abbasivash R, Sane S, Golmohammadi M, Shokuhi S, Toosi FD. Comparing prophylactic effect of phenylephrine and ephedrine on hypotension during spinal anesthesia for hip fracture surgery. Adv Biomed Res. 2016 Oct 26;5:167. doi: 10.4103/2277-9175.190943. eCollection 2016.
- Individual participant dataSharing planned: Undecided. Primary and secondary outcomes will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafał Kowalczyk, PhD principal investigator
I Department of Anaesthesiology and Intensive Care, Infant Jesus Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ephedrine and Phenylephrine in people with Hip Fractures and Elderly Patients, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood preasure (mean arterial pressure, systolic and diastolic blood pressure) (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.