HypotensionNCT06512402
Epinephrine Vs Norepinephrine Infusion During Caesarean Delivery
A study testing Norepinephrine and Epinephrine in people with Hypotension and Spinal Block, run by Cairo University at 1 site in Egypt.
Trial summary
Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension, Spinal Block, Cesarean Section
- What is being tested?
- Norepinephrine and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Dec 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full-term singleton pregnant women, admitted for elective cesarean delivery
Who cannot join
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
- baseline systolic blood pressure (SBP) < 100 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epinephrine Versus Norepinephrine Infusion for Prevention of Maternal Hypotension During Caesarean Delivery: a Randomized Clinical Trial
Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis.
Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes.
There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery
Read the detailed description
Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and 10 mg metoclopramide, and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes; and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick; and will be confirmed if sensory block level is at T4. The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock. The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of <10%.
Hemodynamic management in both groups will be as follow:
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading or systolic blood pressure <90 mmHg during the period from intrathecal injection to delivery of the fetus) will be managed by ephedrine 9 mg Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) will be managed by administration of ephedrine 15 mg Reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading) will be managed (if persisted > 1-reading) by stoppage of the infusion till the next systolic blood pressure reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by stoppage of the vasopressor infusion if not associated with hypotension. The infusion will be then re-started in a reduced rate (50%) when the heart rate is more than 55 bpm. IV atropine bolus (0.5 mg) will be administered if bradycardia persisted despite stoppage of the infusion. If accompanied with hypotension, bradycardia will be managed by IV bolus of ephedrine 9 mg.
Reactive tachycardia (heart rate >130% of baseline) not related to hypotension or ephedrine infusion, will be managed if persisted by stoppage of the infusion. The infusion will be then re-started in a reduced rate (50% of the initial dose) when heart rate will have decreased to be within 30% of the baseline reading.
Fluid administration will be continued up to a maximum of 1.5 liters. After delivery, an oxytocin bolus (0.5 IU) will be delivered over five seconds, followed by infusion at a rate of 2.5 IU/hour.
- Conditions
- Hypotension, Spinal Block, Cesarean Section
- Being tested
- Norepinephrine, Epinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
patients will receive norepinephrine infusion at rate of 0.05 mcg/Kg/min
EpinephrineDrug
patients will receive epinephrine infusion dose of 0.03 mcg/Kg/min
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine group | Active comparator | After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive norepinephrine infusion until 5 min after delivery Receives: Drug: Norepinephrine |
| Epinephrine group | Active comparator | After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive epinephrine infusion until 5 min after delivery Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-spinal hemodynamic instability
the occurrence of either, hypotension, hypertension, bradycardia, and/or tachycardia
Measured: 1 min after spinal anesthesia until 5 min after the delivery
Secondary outcomes (4)
umbilical pH
from umbilical artery
Measured: 5 min after delivery
Apgar
assessment of Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color; Each category is scored with 0, 1, or 2
Measured: 5 min after delivery
heart rate
beat/min
Measured: 1 min after spinal anesthesia until 5 min after the delivery
systolic blood pressure
mmHg
Measured: 1 min after spinal anesthesia until 5 min after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 212 participants (estimated)
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
- NCT06512402
- Sponsor's protocol ID
- MS-376-2023
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the authors upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine Versus Norepinephrine Infusion for Prevention of Maternal Hypotension During Caesarean Delivery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06512402
- Acronym / sponsor ID
- MS-376-2023
- Conditions
- Hypotension, Spinal Block, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jul 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.
Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis.
Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes.
There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery
Detailed description
Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and 10 mg metoclopramide, and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes; and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick; and will be confirmed if sensory block level is at T4. The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock. The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of <10%.
Hemodynamic management in both groups will be as follow:
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading or systolic blood pressure <90 mmHg during the period from intrathecal injection to delivery of the fetus) will be managed by ephedrine 9 mg Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) will be managed by administration of ephedrine 15 mg Reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading) will be managed (if persisted > 1-reading) by stoppage of the infusion till the next systolic blood pressure reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by stoppage of the vasopressor infusion if not associated with hypotension. The infusion will be then re-started in a reduced rate (50%) when the heart rate is more than 55 bpm. IV atropine bolus (0.5 mg) will be administered if bradycardia persisted despite stoppage of the infusion. If accompanied with hypotension, bradycardia will be managed by IV bolus of ephedrine 9 mg.
Reactive tachycardia (heart rate >130% of baseline) not related to hypotension or ephedrine infusion, will be managed if persisted by stoppage of the infusion. The infusion will be then re-started in a reduced rate (50% of the initial dose) when heart rate will have decreased to be within 30% of the baseline reading.
Fluid administration will be continued up to a maximum of 1.5 liters. After delivery, an oxytocin bolus (0.5 IU) will be delivered over five seconds, followed by infusion at a rate of 2.5 IU/hour.
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 |
|---|---|---|
| Norepinephrine group | Active comparator | Drug: NorepinephrineAfter subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive norepinephrine infusion until 5 min after delivery |
| Epinephrine group | Active comparator | Drug: EpinephrineAfter subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive epinephrine infusion until 5 min after delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- full-term singleton pregnant women, admitted for elective cesarean delivery
Key exclusion criteria (5 listed)
- Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- hypertensive disorders of pregnancy,
- peripartum bleeding,
- coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
- baseline systolic blood pressure (SBP) < 100 mmHg
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 |
|---|---|---|
| Norepinephrinepatients will receive norepinephrine infusion at rate of 0.05 mcg/Kg/min | Drug | Norepinephrine group |
| Epinephrinepatients will receive epinephrine infusion dose of 0.03 mcg/Kg/min | Drug | Epinephrine group |
Primary outcome
incidence of post-spinal hemodynamic instability
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
the occurrence of either, hypotension, hypertension, bradycardia, and/or tachycardia
4 secondary outcomes
umbilical pH
Time frame: 5 min after delivery
Apgar
Time frame: 5 min after delivery
heart rate
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
systolic blood pressure
Time frame: 1 min after spinal anesthesia until 5 min after the delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the authors 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 Norepinephrine and Epinephrine in people with Hypotension and Spinal Block, 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 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. 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. 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?
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?
incidence of post-spinal hemodynamic instability (time frame: 1 min after spinal anesthesia until 5 min after the delivery). 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 22 Jul 2024.