AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Egypt1 site
  • Cairo University

    Cairo

Other trials in Egypt

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.

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 groups in NCT06512402
Study groupRoleWhat they receive
Norepinephrine groupActive comparatorAfter 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 groupActive comparatorAfter 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.

  1. 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)
  1. umbilical pH

    from umbilical artery

    Measured: 5 min after delivery

  2. 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

  3. heart rate

    beat/min

    Measured: 1 min after spinal anesthesia until 5 min after the delivery

  4. 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.

  1. First posted22 Jul 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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)
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.

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in