HypotensionNCT05548985
Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population
A study testing Midodrine Oral Tablet and Metoclopramide in people with Hypotension and Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension, Spinal Anesthesia, Elderly
- What is being tested?
- Midodrine Oral Tablet and Metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2022to 15 Jul 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 patients (>65).
- ASA I-II-III.
- Scheduled for hip joint surgery under spinal anaesthesia
Who cannot join
- • Uncontrolled hypertension
- Liver cell failure (child B or C).
- Chronic renal failure on regular dialysis
- Contraindications of spinal anaesthesia
- History of allergy to midodrine
- Cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions).
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- Acute renal disease, urinary retention
- Patients on negative chronotropic drugs (such as beta blocker) or vasoconstrictor
- Patients with glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: : Oral Midodrine for Prophylaxis Against Post Spinal Anaesthesia Hypotension During Hip Arthroplasty in Elderly Population: A Randomized Controlled Trial
Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have systemic medical disorder; therefore, this population is highly vulnerable to perioperative hypotension. Moreover , intraoperative hypotension during hip surgery has been recently recognized as a major risk factor for postoperative morbidity and mortality.
Through the effect of spinal anesthesia on sympathetic system Veno-dilatation, decreased venous return, and consequently decreased cardiac output and hypotension will be induced. Vasopressors are commonly used for prophylaxis against post spinal hypotension in different patient subgroups. The commonly used drugs are alpha-adrenoreceptor agonists such as ephedrine, phenylephrine, and recently norepinephrine. All these agents are effective in maintenance of blood pressure; however, they have some disadvantages; ephedrine is commonly associated with tachycardia, phenylephrine and norepinephrine are associated with bradycardia. All the former mentioned drugs are used intravenously.
Read more
Midodrine hydrochloride is another alpha-adrenoreceptor agonist drug which is used for management of various hypotensive disorders. Midodrine is the prodrug which is metabolized to desglymidodrine which is a direct arteriolar and venous vasopressor. Midodrine is characterized by being an oral drug, with minimal central nervous system side effects, and good oral bioavailability. No studies had evaluated the efficacy of midodrine for prophylaxis against post-spinal anesthesia hypotension in elderly population.
Aim of the work:
This thesis aims to evaluate the efficacy and safety of oral 5 mg of midodrine compared to placebo in prophylaxis against post-spinal hypotension in elderly patients undergoing hip arthroplasty
Read the detailed description
Participants will be instructed to fast for 6 hours for solid light meals and 2 hours for clear fluids. The baseline blood pressure will be measured in the preparation room 90 min before spinal anaesthesia as the mean of three measurements with difference of less than 10%. The patients will receive the study drug after measurement of the baseline blood pressure reading. The patient will be monitored for blood pressure and heart rate at 15 min intervals after administration of the study drug. In the operating room, routine monitors (Electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications will be administrated.
Preoperative evaluation of volume status:
All patients will be assessed for volume status before spinal block through evaluation of the inferior vena cava (IVC) collapsibility, and patients who will show IVC collapsibility > 36% will be considered fluid responders and will receive Ringer's lactate solution, 6 mL/kg ideal body weight over 15 minutes.
IVC collapsibility will be calculated as: (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter.
Anaesthetic management:
Spinal anaesthesia will be performed in the sitting position at level of L3-4 or L4-5 interspaces with a 25-gauge spinal needle. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T6-8 dermatomal level block. If spinal anaesthesia failed, the patient will be excluded from the study and will be managed according to the attending anaesthetist discretion, local expertise and clinical practice. After induction of spinal anaesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Post spinal hypotension will be defined as mean arterial pressure < 80% of the baseline reading 30 minutes after spinal block. Hypotension will be managed by 10 mg ephedrine. Severe hypotension will be defined as mean arterial pressure < 70% of the baseline reading and will be managed by 15 mg ephedrine. The dose of ephedrine will be repeated if the hypotensive episode persisted 2 min after the initial bolus. Bradycardia will be defined as heart rate < 50 bpm and will be managed with 0.5 mg of atropine IV.
Blood loss will be replaced using Ringer's lactate solution at a ratio of 3:1 until transfusion threshold is reached. Further blood loss will be replaced using packed RBCs
- Conditions
- Hypotension, Spinal Anesthesia, Elderly
- Being tested
- Midodrine Oral Tablet, Metoclopramide
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine Oral TabletDrug
oral midodrine tablet (5 mg) 90 min before performing spinal block
MetoclopramideDrug
oral placebo (metoclopramide 10 mg tablet). 90 min before performing spinal block
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | oral metoclopramide 10 mg, Metoclopramide tablet was chosen as a placebo because it has the same appearance of midodrine tablet with no cardiovascular effects Receives: Drug: Metoclopramide |
| Midodrine group | Active comparator | oral midodrine tablet (5 mg) Receives: Drug: Midodrine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative ephedrine consumption
mg
Measured: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Secondary outcomes (5)
Incidence of post-spinal hypotension
defined as mean arterial pressure < 80% of the baseline reading 45 minutes after induction of spinal anesthesia and not related to blood loss
Measured: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of severe spinal induced hypotension
defined as mean arterial pressure < 60% of the baseline reading 45 minutes after induction of spinal anesthesia and not related to blood loss
Measured: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of bradycardia
as heart rate less than 50 beats per minutes
Measured: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
heart rate
beats per minutes
Measured: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
mean arterial pressure
mmHg
Measured: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start17 Oct 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 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 HypotensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548985
- Sponsor's protocol ID
- MD-25-2021
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data supporting this research will be available from the PI upon reasonable request
Publications
Amin S, Hasanin A, Mansour R, Mostafa M, Zakaria D, Arafa AS, Yassin A, Ziada H. Oral midodrine for prophylaxis against post-spinal anesthesia hypotension during hip arthroplasty in elderly population: a randomized controlled trial. BMC Anesthesiol. 2024 Feb 14;24(1):64. doi: 10.1186/s12871-024-02442-8.
PubMed 38355397
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Oral Midodrine for Prophylaxis Against Post Spinal Anaesthesia Hypotension During Hip Arthroplasty in Elderly Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05548985
- Acronym / sponsor ID
- MD-25-2021
- Conditions
- Hypotension, Spinal Anesthesia, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 22 Sep 2022 (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.
Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have systemic medical disorder; therefore, this population is highly vulnerable to perioperative hypotension. Moreover , intraoperative hypotension during hip surgery has been recently recognized as a major risk factor for postoperative morbidity and mortality.
Through the effect of spinal anesthesia on sympathetic system Veno-dilatation, decreased venous return, and consequently decreased cardiac output and hypotension will be induced. Vasopressors are commonly used for prophylaxis against post spinal hypotension in different patient subgroups. The commonly used drugs are alpha-adrenoreceptor agonists such as ephedrine, phenylephrine, and recently norepinephrine. All these agents are effective in maintenance of blood pressure; however, they have some disadvantages; ephedrine is commonly associated with tachycardia, phenylephrine and norepinephrine are associated with bradycardia. All the former mentioned drugs are used intravenously.
Midodrine hydrochloride is another alpha-adrenoreceptor agonist drug which is used for management of various hypotensive disorders. Midodrine is the prodrug which is metabolized to desglymidodrine which is a direct arteriolar and venous vasopressor. Midodrine is characterized by being an oral drug, with minimal central nervous system side effects, and good oral bioavailability. No studies had evaluated the efficacy of midodrine for prophylaxis against post-spinal anesthesia hypotension in elderly population.
Aim of the work:
This thesis aims to evaluate the efficacy and safety of oral 5 mg of midodrine compared to placebo in prophylaxis against post-spinal hypotension in elderly patients undergoing hip arthroplasty
Detailed description
Participants will be instructed to fast for 6 hours for solid light meals and 2 hours for clear fluids. The baseline blood pressure will be measured in the preparation room 90 min before spinal anaesthesia as the mean of three measurements with difference of less than 10%. The patients will receive the study drug after measurement of the baseline blood pressure reading. The patient will be monitored for blood pressure and heart rate at 15 min intervals after administration of the study drug. In the operating room, routine monitors (Electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications will be administrated.
Preoperative evaluation of volume status:
All patients will be assessed for volume status before spinal block through evaluation of the inferior vena cava (IVC) collapsibility, and patients who will show IVC collapsibility > 36% will be considered fluid responders and will receive Ringer's lactate solution, 6 mL/kg ideal body weight over 15 minutes.
IVC collapsibility will be calculated as: (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter.
Anaesthetic management:
Spinal anaesthesia will be performed in the sitting position at level of L3-4 or L4-5 interspaces with a 25-gauge spinal needle. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T6-8 dermatomal level block. If spinal anaesthesia failed, the patient will be excluded from the study and will be managed according to the attending anaesthetist discretion, local expertise and clinical practice. After induction of spinal anaesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Post spinal hypotension will be defined as mean arterial pressure < 80% of the baseline reading 30 minutes after spinal block. Hypotension will be managed by 10 mg ephedrine. Severe hypotension will be defined as mean arterial pressure < 70% of the baseline reading and will be managed by 15 mg ephedrine. The dose of ephedrine will be repeated if the hypotensive episode persisted 2 min after the initial bolus. Bradycardia will be defined as heart rate < 50 bpm and will be managed with 0.5 mg of atropine IV.
Blood loss will be replaced using Ringer's lactate solution at a ratio of 3:1 until transfusion threshold is reached. Further blood loss will be replaced using packed RBCs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Metoclopramideoral metoclopramide 10 mg, Metoclopramide tablet was chosen as a placebo because it has the same appearance of midodrine tablet with no cardiovascular effects |
| Midodrine group | Active comparator | Drug: Midodrine Oral Tabletoral midodrine tablet (5 mg) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly patients (>65).
- ASA I-II-III.
- Scheduled for hip joint surgery under spinal anaesthesia
Key exclusion criteria (9 listed)
- • Uncontrolled hypertension
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 |
|---|---|---|
| Midodrine Oral Tabletoral midodrine tablet (5 mg) 90 min before performing spinal block | Drug | Midodrine group |
| Metoclopramideoral placebo (metoclopramide 10 mg tablet). 90 min before performing spinal block | Drug | control group |
Primary outcome
Intraoperative ephedrine consumption
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
mg
5 secondary outcomes
Incidence of post-spinal hypotension
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of severe spinal induced hypotension
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
Incidence of bradycardia
Time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia
heart rate
Time frame: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
mean arterial pressure
Time frame: 1 minute after intervention, every 15 minutes after intervention for 90 minutes, every 2 minutes after spinal anesthesia for 20 min, then every 5 minutes until the end of the procedure
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 15 Sep 2023.
- Derived from this study: PubMed 38355397Amin S, Hasanin A, Mansour R, Mostafa M, Zakaria D, Arafa AS, Yassin A, Ziada H. Oral midodrine for prophylaxis against post-spinal anesthesia hypotension during hip arthroplasty in elderly population: a randomized controlled trial. BMC Anesthesiol. 2024 Feb 14;24(1):64. doi: 10.1186/s12871-024-02442-8.
- Individual participant dataSharing planned: No. data supporting this research will be available from the PI upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine Oral Tablet and Metoclopramide in people with Hypotension and Spinal Anesthesia, run by Cairo University at 1 site in Egypt.
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 9 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 15 Sep 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Intraoperative ephedrine consumption (time frame: 1 minutes after spinal injection until 45 minutes after induction of spinal anesthesia). 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 NCT05548985, 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 15 Sep 2023.