EphedrinePhase 4NCT05498857
Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia
A Phase 4 study testing Intramuscular ephedrine in people with Ephedrine and Intramuscular, run by Hospital de Base at 1 site in Brazil.
Trial summary
Subarachnoid anesthesia is an alternative and usually the first choice for many surgical procedures. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ephedrine, Intramuscular, Hypotension
- What is being tested?
- Intramuscular ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2022to Jul 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Who cannot join
- Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
- Patients with atrioventricular block
- Patients with cardiac arrhythmias
- Patients with heart failure;
- Patients with renal disease
- Patients with liver disease
- Patient carrying or suspecting any type of systemic infection or located in a puncture site;
- Patients who refuse to participate in the study after presenting the free and informed consent form;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Base do Distrito Federal
Brasília, Federal District, 70330-150
Nadja Graca, MD, 556133151588, uamphbdf@gmail.com
About this study
Official title: Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Prospective, Randomized, Double-blind, Placebo-controlled Trial
Subarachnoid anesthesia is an alternative and usually the first choice for many surgical procedures. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. In this sense, ephedrine, an alpha and beta agonist agent, commonly used as rescue therapy for these events, is also potentially useful for prophylaxis of this unwanted effect and for less hemodynamic variation when preventively administered via the intramuscular route. Two groups will be divided: intramuscular ephedrine (0.5 mg/kg) and placebo. The variables analyzed and compared will be the incidence of hypotension and bradycardia, variation in mean and systolic blood pressure, heart rate, in addition to side effects. The main objective is to verify if the use of intramuscular ephedrine prior to spinal block is able to reduce the incidence of hypotension.
Read the detailed description
Subarachnoid or spinal anesthesia is an alternative and usually the first choice for many surgical procedures of the lower limbs, perineum and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. The incidence of hypotension and bradycardia is approximately 30 and 10%, respectively, during spinal anesthesia, however, the incidence of hypotension can be as high as 50 to 60% in obstetric patients.
In this sense, it is common for ephedrine, an agent with beta and alpha agonist action, to be the medication of first choice for rescuing hypotension and bradycardia after subarachnoid block, with part of its action happening by a direct mechanism and part by stimulus and indirect release. of endogenous catecholamines stored in the adrenal.
It is known that intramuscular administration has slower absorption and lower bioavailability of the drug compared to intravenous administration. Therefore, we have in our favor: a later serum peak, coinciding with the establishment of sympathetic block after spinal anesthesia, as well as more insidious effects, with less tendency to peaks and valleys and greater hemodynamic stability when compared to therapy alone. intravenous rescue. To assess this response, the main objective of the present study is to verify the hypothesis that the previous administration of ephedrine by intramuscular route reduces the incidence of hypotension induced by spinal anesthesia.
The proposal is a prospective, randomized, double-blind, placebo-controlled study in surgical procedures. Examiners responsible for evaluating patients will not have access to the agents used. Patients will be randomized through a list generated by lottery. The examiner responsible for opening the envelope, will perform the drawing, include the patient in one of the groups, write down his/her data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the following examiners will not be aware of the administered drug.
Patients will receive standard monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. Then, the study drug will be administered (ephedrine 0.3mg/kg intramuscularly or placebo). All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist, except clonidine.
The evolution of vital signs such as systolic and mean blood pressure, heart rate, height of sensory block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, consumption of vasopressors and antiemetics will be evaluated.
- Conditions
- Ephedrine, Intramuscular, Hypotension, Spinal Anesthesia
- Being tested
- Intramuscular ephedrine, Placebo
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ephedrineDrug
Patients will receive prophylactic intramuscular ephedrine plus standard spinal anesthesia
PlaceboDrug
Patients will receive prophylactic intramuscular saline plus standard spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine group | Active comparator | Patients will receive intramuscular ephedrine 0,5 mg/kg before spinal anesthesia Receives: Drug: Intramuscular ephedrine; Drug: Placebo |
| Placebo group | Placebo comparator | Patients will receive intramuscular saline before spinal anesthesia Receives: Drug: Intramuscular ephedrine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as hypotension
Intraoperative hemodynamic stability analysis through the incidence of bradycardia, hypotension and consumed vasopressors
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start15 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EphedrineStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind and placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonca, MD, MSc, PhD, Principal investigator, Hospital de Base do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498857
- Sponsor's protocol ID
- i.m. ephedrine
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia: a Prospective, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05498857
- Acronym / sponsor ID
- i.m. ephedrine
- Conditions
- Ephedrine, Intramuscular, Hypotension, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 12 Aug 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.
Subarachnoid anesthesia is an alternative and usually the first choice for many surgical procedures. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. In this sense, ephedrine, an alpha and beta agonist agent, commonly used as rescue therapy for these events, is also potentially useful for prophylaxis of this unwanted effect and for less hemodynamic variation when preventively administered via the intramuscular route. Two groups will be divided: intramuscular ephedrine (0.5 mg/kg) and placebo. The variables analyzed and compared will be the incidence of hypotension and bradycardia, variation in mean and systolic blood pressure, heart rate, in addition to side effects. The main objective is to verify if the use of intramuscular ephedrine prior to spinal block is able to reduce the incidence of hypotension.
Detailed description
Subarachnoid or spinal anesthesia is an alternative and usually the first choice for many surgical procedures of the lower limbs, perineum and lower abdomen. It is a simple and safe procedure, however it can present complications such as hypotension and bradycardia. The incidence of hypotension and bradycardia is approximately 30 and 10%, respectively, during spinal anesthesia, however, the incidence of hypotension can be as high as 50 to 60% in obstetric patients.
In this sense, it is common for ephedrine, an agent with beta and alpha agonist action, to be the medication of first choice for rescuing hypotension and bradycardia after subarachnoid block, with part of its action happening by a direct mechanism and part by stimulus and indirect release. of endogenous catecholamines stored in the adrenal.
It is known that intramuscular administration has slower absorption and lower bioavailability of the drug compared to intravenous administration. Therefore, we have in our favor: a later serum peak, coinciding with the establishment of sympathetic block after spinal anesthesia, as well as more insidious effects, with less tendency to peaks and valleys and greater hemodynamic stability when compared to therapy alone. intravenous rescue. To assess this response, the main objective of the present study is to verify the hypothesis that the previous administration of ephedrine by intramuscular route reduces the incidence of hypotension induced by spinal anesthesia.
The proposal is a prospective, randomized, double-blind, placebo-controlled study in surgical procedures. Examiners responsible for evaluating patients will not have access to the agents used. Patients will be randomized through a list generated by lottery. The examiner responsible for opening the envelope, will perform the drawing, include the patient in one of the groups, write down his/her data in the random list, prepare the syringe with the medication, and deliver it to the operating room so that the following examiners will not be aware of the administered drug.
Patients will receive standard monitoring, venoclysis, intravenous midazolam as pre-anesthetic medication. Then, the study drug will be administered (ephedrine 0.3mg/kg intramuscularly or placebo). All patients received spinal anesthesia with hyperbaric bupivacaine and opioid adjuvants at the discretion of the anesthesiologist, except clonidine.
The evolution of vital signs such as systolic and mean blood pressure, heart rate, height of sensory block, incidence of adverse events such as bradycardia, tachycardia, hypertension or hypotension, nausea, vomiting, consumption of vasopressors and antiemetics will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind and placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ephedrine group | Active comparator | Drug: Intramuscular ephedrine, Drug: PlaceboPatients will receive intramuscular ephedrine 0,5 mg/kg before spinal anesthesia |
| Placebo group | Placebo comparator | Drug: Intramuscular ephedrine, Drug: PlaceboPatients will receive intramuscular saline before spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old, electively scaled for surgery requiring neuraxial block, with programming of spinal anesthesia.
- Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
Key exclusion criteria (8 listed)
- Patients taking prophylactic or therapeutic anticoagulation, except respecting the allowed range;
- Patients with atrioventricular block
- Patients with cardiac arrhythmias
- Patients with heart failure;
- Patients with renal disease
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 |
|---|---|---|
| Intramuscular ephedrinePatients will receive prophylactic intramuscular ephedrine plus standard spinal anesthesia | Drug | Ephedrine group, Placebo group |
| PlaceboPatients will receive prophylactic intramuscular saline plus standard spinal anesthesia | Drug | Ephedrine group, Placebo group |
Primary outcome
Number of participants with adverse events as hypotension
Time frame: During surgery
Intraoperative hemodynamic stability analysis through the incidence of bradycardia, hypotension and consumed vasopressors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
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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.
Fabricio T Mendonca, MD, MSc, PhD principal investigator
Hospital de Base do Distrito Federal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intramuscular ephedrine in people with Ephedrine and Intramuscular, run by Hospital de Base at 1 site in Brazil.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabricio T Mendonca, MD, MSc, PhD (5561981882640, correiodofabricio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as hypotension (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2022.