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.
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.
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 group | Role | What they receive |
|---|---|---|
| Group Adrenaline: Group A | Active comparator | All 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 E | Active comparator | All 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.
delta SBP (D)
difference between baseline and the lowest systolic blood pressure.
Measured: at the end of intrathecal injection until delivery
delta MBP (D)
difference between baseline and the lowest mean blood pressure.
Measured: at the end of intrathecal injection until delivery
Secondary outcomes (15)
delta SBP (S)
difference between baseline and the lowest systolic blood pressure.
Measured: at the end of intrathecal injection until the end of surgery
delta MBP (S)
difference between baseline and the lowest mean blood pressure.
Measured: at the end of intrathecal injection until the end of surgery
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)
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)
Vasopressor consumption
cumulative dose of vasopressor consumption
Measured: from the end of intrathecal injection until delivery.
Vasopressor consumption
cumulative dose of vasopressor consumption
Measured: from the end of intrathecal injection until the end of surgery.
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)
incidence of hypertension
a rise of SBP >20% of baseline
Measured: At time of surgery (right after spinal anesthesia until end of surgery)
tachycardia
heart rate>140 beats/min
Measured: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of arrythmia
incidence of arrhythmic events
Measured: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of bradycardia
heart rate (HR) < 50 beats/min
Measured: At time of surgery (right after spinal anesthesia until end of surgery)
use of atropine
cumulative dose, if needed
Measured: At time of surgery (right after spinal anesthesia until end of surgery)
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)
foetal gas analysis: pH, Lactates, HCO3-, BE
fetal cord blood analysis will be done immediately after delivery
Measured: At time of birth
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.
- First posted15 Oct 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ben marzouk Sofiene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- HAYEN MAGHREBIG, PROFESSOR, Study chair, UNIVERSITY OF TUNIS EL MANAR
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT03704909
- Acronym / sponsor ID
- EpiEph / Adrenaline
- Conditions
- Hypotension
- Keywords
- Epinephrine, Ephedrine, cesarean section, spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ben marzouk SofieneUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Oct 2018 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Adrenaline: Group A | Active comparator | Drug: AdrenalineAll 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. |
| Group Ephedrine: Group E | Active comparator | Drug: EphedrineAll 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- ASA II
- BMI>18 and <35 Kg/m2
- full term parturients with singleton pregnancy
- scheduled of elective cesarean section under spinal anesthesia
- Patient refusal.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| AdrenalineAlso: epinehrinei.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg | Drug | Group Adrenaline: Group A |
| Ephedrinei.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg | Drug | Group Ephedrine: Group E |
Primary outcome
delta SBP (D)
Time frame: at the end of intrathecal injection until delivery
difference between baseline and the lowest systolic blood pressure.
delta MBP (D)
Time frame: at the end of intrathecal injection until delivery
difference between baseline and the lowest mean blood pressure.
15 secondary outcomes
delta SBP (S)
Time frame: at the end of intrathecal injection until the end of surgery
delta MBP (S)
Time frame: at the end of intrathecal injection until the end of surgery
time to onset of first post spinal hypotension episode
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
Incidence of post spinal hypotension
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
Vasopressor consumption
Time frame: from the end of intrathecal injection until delivery.
Vasopressor consumption
Time frame: from the end of intrathecal injection until the end of surgery.
number of rescue boluses
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of hypertension
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
tachycardia
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of arrythmia
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of bradycardia
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
use of atropine
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
incidence of nausea and vomiting
Time frame: At time of surgery (right after spinal anesthesia until end of surgery)
foetal gas analysis: pH, Lactates, HCO3-, BE
Time frame: At time of birth
APGAR score
Time frame: at 1 and 5 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
HAYEN MAGHREBIG, PROFESSOR study chair
UNIVERSITY OF TUNIS EL MANAR
1 site in 1 country: see every site and its status.
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.