Post Spinal Anesthesia HypotensionNCT06213935
Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial
A study testing Norepinephrine and Midodrine in people with Post Spinal Anesthesia Hypotension, run by Sohag University.
Trial summary
Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Anesthesia Hypotension
- What is being tested?
- Norepinephrine and Midodrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Nov 2024
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include 90 adult female patients, 45 in each group (between 18-35 years old).
- patients of ASA physical status class I and class II.
- patients scheduled for elective cesarean section under spinal anesthesia.
Who cannot join
- Patient refusal.
- Contraindication to spinal anesthesia .
- Patients known allergic to Midodrine or Norepinephrine.
- Patients with preexisting cardiovascular or cerebrovascular disease.
- Patients with diabetes mellitus.
- Patients with psychiatric disease or on psychiatric treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.
Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.
On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.
- Conditions
- Post Spinal Anesthesia Hypotension
- Being tested
- Norepinephrine, Midodrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
after spinal anesthesia, norepinephrine will be injected intravenous as bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min to prevent post spinal hypotension
MidodrineDrug
10 mg tablets of midodrine 1 hour before spinal anesthesia to prevent post spinal anesthesia hypotension
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | will receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min Receives: Drug: Norepinephrine |
| Group B | Active comparator | will receive 10 mg tablets of midodrine 1 hour before spinal anesthesia. Receives: Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post spinal anesthesia hypotension
decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading
Measured: within 60 minutes of induction of spinal anesthesia
Secondary outcomes (2)
Intraoperative ephedrine consumption
ephedrine dose injected intravenous to control post spinal hypotension
Measured: within 60 minutes of induction of spinal anesthesia
Incidence of post spinal anesthesia bradycardia
decrease in Heart Rate less than 50 Beats per minutes
Measured: within 60 minutes of induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Spinal Anesthesia HypotensionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Ramsis Khalafallah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213935
- Sponsor's protocol ID
- Soh-Med-23-12-01MS
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.
PubMed 8329261Alseoudy MM, Nasr MO, Abdelsalam TA. Efficacy of Preoperative Oral Midodrine in Preventing Hypotension After Spinal Anesthesia in Young Adults: A Randomized Controlled Trial. Anesth Analg. 2022 Nov 1;135(5):1089-1096. doi: 10.1213/ANE.0000000000006173. Epub 2022 Aug 10.
PubMed 35950781Quaglia MG, Farina A, Palmery M, Desideri N, Donati E, Bossu E, Strano S. Chiral investigation of midodrine, a long-acting alpha-adrenergic stimulating agent. Chirality. 2004 Jul;16(6):356-62. doi: 10.1002/chir.20041.
PubMed 15190580Gutman LB, Wilson BJ. The Role of Midodrine for Hypotension Outside of the Intensive Care Unit. J Popul Ther Clin Pharmacol. 2017 Aug 23;24(3):e45-e50. doi: 10.22374/1710-6222.24.3.4.
PubMed 28873293
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06213935
- Acronym / sponsor ID
- Soh-Med-23-12-01MS
- Conditions
- Post Spinal Anesthesia Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 19 Jan 2024 (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.
Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.
Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.
On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Norepinephrinewill receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min |
| Group B | Active comparator | Drug: Midodrinewill receive 10 mg tablets of midodrine 1 hour before spinal anesthesia. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The study will include 90 adult female patients, 45 in each group (between 18-35 years old).
- patients of ASA physical status class I and class II.
- patients scheduled for elective cesarean section under spinal anesthesia.
Key exclusion criteria (6 listed)
- Patient refusal.
- Contraindication to spinal anesthesia .
- Patients known allergic to Midodrine or Norepinephrine.
- Patients with preexisting cardiovascular or cerebrovascular disease.
- Patients with diabetes mellitus.
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 |
|---|---|---|
| Norepinephrineafter spinal anesthesia, norepinephrine will be injected intravenous as bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min to prevent post spinal hypotension | Drug | group A |
| Midodrine10 mg tablets of midodrine 1 hour before spinal anesthesia to prevent post spinal anesthesia hypotension | Drug | Group B |
Primary outcome
Incidence of post spinal anesthesia hypotension
Time frame: within 60 minutes of induction of spinal anesthesia
decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading
2 secondary outcomes
Intraoperative ephedrine consumption
Time frame: within 60 minutes of induction of spinal anesthesia
Incidence of post spinal anesthesia bradycardia
Time frame: within 60 minutes of induction of spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 8329261McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.
- Background: PubMed 35950781Alseoudy MM, Nasr MO, Abdelsalam TA. Efficacy of Preoperative Oral Midodrine in Preventing Hypotension After Spinal Anesthesia in Young Adults: A Randomized Controlled Trial. Anesth Analg. 2022 Nov 1;135(5):1089-1096. doi: 10.1213/ANE.0000000000006173. Epub 2022 Aug 10.
- Background: PubMed 15190580Quaglia MG, Farina A, Palmery M, Desideri N, Donati E, Bossu E, Strano S. Chiral investigation of midodrine, a long-acting alpha-adrenergic stimulating agent. Chirality. 2004 Jul;16(6):356-62. doi: 10.1002/chir.20041.
- Background: PubMed 28873293Gutman LB, Wilson BJ. The Role of Midodrine for Hypotension Outside of the Intensive Care Unit. J Popul Ther Clin Pharmacol. 2017 Aug 23;24(3):e45-e50. doi: 10.22374/1710-6222.24.3.4.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Midodrine in people with Post Spinal Anesthesia Hypotension, run by Sohag University.
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 6 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew R Khalafallah, Resident (01284160711, andrewramsis@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post spinal anesthesia hypotension (time frame: within 60 minutes of 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 NCT06213935, which also lists 4 linked publications.
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 19 Jan 2024.