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AzTrials

Cesarean Section ComplicationsPhase 4NCT03234816

Vasopressor Prophylaxis After Spinal Anesthesia

A Phase 4 study testing Norepinephrine 0.05 mcg /Kg/min, Norepinephrine 0.1 mcg /Kg/min and Norepinephrine 0.15 mcg /Kg/min in people with Cesarean Section Complications, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Cesarean Section Complications
What is being tested?
Norepinephrine 0.05 mcg /Kg/min, Norepinephrine 0.1 mcg /Kg/min and Norepinephrine 0.15 mcg /Kg/min
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteEgypt
Study dates
2 Aug 2017to 10 Dec 2018
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 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • full term singleton pregnant women
  • Scheduled for elective Cesarean Delivery
  • Aged between 18 and 40 years

Who cannot join

  • Cardiac morbidities
  • Hypertensive disorders of pregnancy,
  • Peripartum bleeding
  • Baseline systolic blood pressure (SBP) < 100 mmHg
  • Body mass index > 35

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

Read the detailed description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

Being tested
Norepinephrine 0.05 mcg /Kg/min, Norepinephrine 0.1 mcg /Kg/min, Norepinephrine 0.15 mcg /Kg/min, Bupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norepinephrine 0.05 mcg /Kg/minDrug

    Also called noradrenaline infusion

    Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

  • Norepinephrine 0.1 mcg /Kg/minDrug

    Also called noradrenaline infusion

    Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

  • Norepinephrine 0.15 mcg /Kg/minDrug

    Also called noradrenaline infusion

    Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia

  • BupivacaineDrug

    Also called marcaine

    10 mg Bupivacaine intra-thecal for spinal anesthesia

Study groups in NCT03234816
Study groupRoleWhat they receive
- 0.05 mcg /Kg/min groupExperimentalwill receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Receives: Drug: Norepinephrine 0.05 mcg /Kg/min; Drug: Bupivacaine
- 0.1 mcg /Kg/min groupExperimentalwill receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Receives: Drug: Norepinephrine 0.1 mcg /Kg/min; Drug: Bupivacaine
- 0.15 mcg /Kg/min groupExperimentalwill receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
Receives: Drug: Norepinephrine 0.15 mcg /Kg/min; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of postspinal hypotension

    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

    Measured: 30 minutes after spinal anesthesia

Secondary outcomes (8)

  1. heart rate

    heart rate after spinal anesthesia measured in beat per minute

    Measured: 90 minutes after spinal anesthesia

  2. vomiting

    incidence of vomiting after spinal anesthesia

    Measured: 120 minutes after spinal anesthesia

  3. nausea

    incidence of nausea after spinal anesthesia

    Measured: 120 minutes after spinal anesthesia

  4. ephedrine consumption

    total amount of ephedrine consumed after spinal anesthesia

    Measured: 60 minutes after spinal anesthesia

  5. Atropine consumption

    total amount of atropine consumed after spinal anesthesia

    Measured: 60 minutes after spinal anesthesia

  6. APGAR score

    APGAR score of the delivered fetus

    Measured: 10 minutes after delivery

  7. incidence of severe postspinal hypotension

    The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

    Measured: 30 minutes after spinal anesthesia

  8. arterial blood pressure

    arterial blood pressure after spinal anesthesia measured in mmHg

    Measured: 90 minutes after spinal anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start2 Aug 2017
  3. Primary completion2 Nov 2018
  4. Study completion10 Dec 2018

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234816
Sponsor's protocol ID
N_66_2017
Status last verified
Jan 2019
First submitted
27 Jul 2017
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Norepinephrine 0.05 mcg /Kg/min, Norepinephrine 0.1 mcg /Kg/min and Norepinephrine 0.15 mcg /Kg/min in people with Cesarean Section Complications, 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 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: finished, as of the sponsor's last update on 15 Jan 2019. 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.

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?

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?

incidence of postspinal hypotension (time frame: 30 minutes after 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 NCT03234816.

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 Jan 2019.

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