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HypotensionPhase 4EpiEphNCT03704909

Manging Post Spinal Hypotension During Elective Cesarean Section

A Phase 4 study testing Adrenaline and Ephedrine in people with Hypotension, run by Ben marzouk Sofiene at 1 site in Tunisia.

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

Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypotension
What is being tested?
Adrenaline and Ephedrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteTunisia
Study dates
1 Sep 2018to 31 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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ASA II
  • BMI>18 and <35 Kg/m2
  • full term parturients with singleton pregnancy
  • scheduled of elective cesarean section under spinal anesthesia
  • Non-inclusion criteria:
  • Patient refusal.
Show all 17Show fewer
  • ASA > II
  • Preexisting or pregnancy-induced hypertension
  • The use of cardiac medication or medication for BP control.
  • Cardiovascular or cerebrovascular disease.
  • Multiple pregnancy.
  • Suspicion of abnormal placentation.
  • Known fetal abnormalities or fetal distress.
  • CS under general anesthesia.
  • Active labor.
  • Emergency.
  • Allergy to any of the medications used in the study.

Who cannot join

  • Hemodynamic instability that is not in relationship with SA (occurrence of a surgical per-operative complication e.g. bleeding by placental insertion abnormality or a uterine atony).
  • An abnormal extension of the anesthetic block defined as a sensory block level > D4.
  • SA failure.
  • The need to convert to general anesthesia.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Tunis maternity and neonatology center,

    Tunis, 1007

Other trials in Tunisia

About this study

Official title: Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial

Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Read the detailed description

Its a prospective double-blinded controlled trial. All participants gave a written informed consent. One hundred and twenty healthy women, ASA II, with singleton pregnancies at term scheduled for elective cesarean section under spinal anesthesia are targeted for the study. They are randomized to receive either epinephrine or ephedrine. Upon arrival in the operating room, parturient was placed in the supine position with 15° left lateral tilt with routine monitoring (HR, non-invasive BP, pulse oximetry, electrocardiography). Baseline BP and HR were computed as the mean of three consecutive BP and HR readings respectively at 1-minute intervals. Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus sufentanil (5 µg) at L3-4 vertebral interspace.

Group A (for adrenaline group): received a prophylactic intravenous (i.v) bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, were given if maternal BP decreased more than 20% from the baseline value.

Group E (for ephedrine group): received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, were given if maternal BP decreased more than 20% from the baseline value. Once the spinal injection was performed a rapid intravenous (i.v.) coload with 15mL/Kg of isotonic saline solution was started through a 16 G i.v. cannula (by turning the i.v. infusion to maximum and using a pressure bag inflated to 150 mmHg). A prophylactic bolus of vasopressor was administered at the end of spinal injection. After performing anesthesia, the parturient was immediately replaced in the supine position with a 15° left lateral table tilt until delivery of the infant. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. Sensory block level was checked by cold-hot test and the Modified Bromage Scale was used for the assessment of motor block. The surgery was allowed when the sensory block level reached D4. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Epinephrine or Ephedrine bolus. Supplemental oxygen will be given only when the pulse oximeter reading decreased below 95%. After delivery, 5 IU of oxytocin diluted in 20 ml of isotonic saline solution were slowly injected over 1 minute. Then an i.v infusion was given (10 IU/500ml of isotonic saline solution at a flow rate of 28 drops/min).

Heart rate (beats/min), systolic, mean and diastolic blood pressure (mmHg) will be recorded every 1 min after spinal injection until the end of surgery. The incidence of hypotension (defined as a reduction in SBP of >20% from baseline determined just before the administration of spinal anesthesia) will be recorded. Reactive hypertension (defined as a rise of SBP >20% of baseline) will also be recorded. Bradycardia (defined as HR <50 beats/min) will be recorded. Tachycardia (defined as a HR >140 beats/min) will also be recorded. Umbilical blood samples will be obtained by clamping it on both sides and a gas analysis will be performed to determine fetal pH, HCO3-, base excess and lactates. Furthermore, Apgar scores at 1 and 5 minutes after delivery will be recorded by the attending pediatrician, who will be unaware of the vasopressor used. The study will end when cesarean section is completed and the patient is transferred to the post-operative care unit.

Conditions
Hypotension
Being tested
Adrenaline, Ephedrine
Keywords
Epinephrine, Ephedrine, cesarean section, spinal anesthesia
Medical subject headings
Hypotension

What participants receive

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

  • AdrenalineDrug

    Also called epinehrine

    i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg

  • EphedrineDrug

    i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg

Study groups in NCT03704909
Study groupRoleWhat they receive
Group Adrenaline: Group AActive comparatorAll parturients received a prophylactic i.v bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.
Receives: Drug: Adrenaline
Group Ephedrine: Group EActive comparatorAll parturients received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.E
Receives: Drug: Ephedrine

What is being measured

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

  1. delta SBP (D)

    difference between baseline and the lowest systolic blood pressure.

    Measured: at the end of intrathecal injection until delivery

  2. delta MBP (D)

    difference between baseline and the lowest mean blood pressure.

    Measured: at the end of intrathecal injection until delivery

Secondary outcomes (15)
  1. delta SBP (S)

    difference between baseline and the lowest systolic blood pressure.

    Measured: at the end of intrathecal injection until the end of surgery

  2. delta MBP (S)

    difference between baseline and the lowest mean blood pressure.

    Measured: at the end of intrathecal injection until the end of surgery

  3. time to onset of first post spinal hypotension episode

    first episode of hypotension after spinal anesthesia induction

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  4. Incidence of post spinal hypotension

    a decrease of SBP >20% of baseline

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  5. Vasopressor consumption

    cumulative dose of vasopressor consumption

    Measured: from the end of intrathecal injection until delivery.

  6. Vasopressor consumption

    cumulative dose of vasopressor consumption

    Measured: from the end of intrathecal injection until the end of surgery.

  7. number of rescue boluses

    number of rescue boluses before and after delivery

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  8. incidence of hypertension

    a rise of SBP >20% of baseline

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  9. tachycardia

    heart rate>140 beats/min

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  10. incidence of arrythmia

    incidence of arrhythmic events

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  11. incidence of bradycardia

    heart rate (HR) < 50 beats/min

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  12. use of atropine

    cumulative dose, if needed

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  13. incidence of nausea and vomiting

    Measure will be done according to a simple scale: 0= no nausea and vomiting; 1= nausea or vomiting

    Measured: At time of surgery (right after spinal anesthesia until end of surgery)

  14. foetal gas analysis: pH, Lactates, HCO3-, BE

    fetal cord blood analysis will be done immediately after delivery

    Measured: At time of birth

  15. APGAR score

    range from 0 to 10,incorporates five elements: respiratory effort, heart rate, reflex irritability, muscle tone, and color A score of 0 to 3 indicates a severely depressed neonate, whereas a score of 7 to 10 is considered normal.

    Measured: at 1 and 5 minutes after birth

Timeline

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

  1. First posted15 Oct 2018
  2. Study start1 Sep 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 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, Care provider, Investigator
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03704909
Sponsor's protocol ID
Adrenaline
Acronym
EpiEph
Status last verified
Mar 2019
First submitted
10 Oct 2018
Last updated
13 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adrenaline and Ephedrine in people with Hypotension, run by Ben marzouk Sofiene at 1 site in Tunisia.

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 17 inclusion and 4 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 13 Mar 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 Tunisia. 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?

delta SBP (D) (time frame: at the end of intrathecal injection until delivery). The study lists 2 primary outcomes in all. 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 13 Mar 2019.

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