Postspinal HypotensionPhase 4NCT05279703
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery
A Phase 4 study testing Epinephrine 0.03, Epinephrin 0.02 and Epinephrin 0.01 in people with Postspinal Hypotension and Cesarean Delivery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postspinal Hypotension, Cesarean Delivery, Epinephrine
- What is being tested?
- Epinephrine 0.03, Epinephrin 0.02 and Epinephrin 0.01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2022to Aug 2022
- 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
- American society of anesthesiologist-physical status I or II,
- scheduled 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,
- and baseline systolic blood pressure (SBP) < 100 mmHg
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini Hospital
Cairo, 11562
Anesthesia, Pain Management and Surgical ICU Department, 00201222224057, Anesthesia.kasralainy@gmail.com
About this study
Official title: The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.
Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.
In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
Read the detailed description
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into 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 the vasopressor infusion will be started.
- 0.01 mcg group
- 0.02 mcg group
- 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.
Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.
- Conditions
- Postspinal Hypotension, Cesarean Delivery, Epinephrine
- Being tested
- Epinephrine 0.03, Epinephrin 0.02, Epinephrin 0.01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 0.03Drug
Also called adrenaline
epinephrine infusion rate of 0.03 mcg/kg/min
Epinephrin 0.02Drug
Also called adrenaline
epinephrine infusion rate of 0.02 mcg/kg/min
Epinephrin 0.01Drug
Also called adrenaline
epinephrine infusion rate of 0.01 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| 0.03 mcg group | Active comparator | epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby Receives: Drug: Epinephrine 0.03 |
| 0.02 mcg group | Active comparator | epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby Receives: Drug: Epinephrin 0.02 |
| 0.01 mcg group | Active comparator | epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby Receives: Drug: Epinephrin 0.01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postspinal hypotension
systolic blood pressure ≤80% of the baseline reading
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
Secondary outcomes (12)
incidence of tachycardia
heart rate > 130% of baseline
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of hypertension
systolic blood pressure >120% of baseline
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of severe hypotension
systolic blood pressure ≤60% of the baseline reading
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mean heart rate
beat per minute
Measured: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mean systolic blood pressure
mmHg
Measured: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
total ephedrine requirement
mg
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
total atropine requirement
mg
Measured: 1 minute after subarachnoid injection till 5 minutes after baby delivery
Apgar score
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
Measured: 5 minutes after delivery
umbilical blood pH
pH
Measured: 5 minutes after delivery
umbilical blood PCO2
mmHg
Measured: 5 minutes after delivery
umbilical blood PO2
mmHg
Measured: 5 minutes after delivery
umbilical blood HCO3
mmol/L
Measured: 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start21 Mar 2022
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postspinal 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279703
- Sponsor's protocol ID
- MD-399-2021
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available from PI upon reasonable request
Publications
Hasanin AM, Abou Amer A, Hassabelnaby YS, Mostafa M, Abdelnasser A, Amin SM, Elsherbiny M, Refaat S. The use of epinephrine infusion for the prevention of spinal hypotension during Caesarean delivery: A randomized controlled dose-finding trial. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101204. doi: 10.1016/j.accpm.2023.101204. Epub 2023 Feb 28.
PubMed 36858257
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial
- ClinicalTrials.gov ID
- NCT05279703
- Acronym / sponsor ID
- MD-399-2021
- Conditions
- Postspinal Hypotension, Cesarean Delivery, Epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 15 Mar 2022 (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.
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.
Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.
In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
Detailed description
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into 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 the vasopressor infusion will be started.
- 0.01 mcg group
- 0.02 mcg group
- 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.
Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.
Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.
Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.03 mcg group | Active comparator | Drug: Epinephrine 0.03epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby |
| 0.02 mcg group | Active comparator | Drug: Epinephrin 0.02epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby |
| 0.01 mcg group | Active comparator | Drug: Epinephrin 0.01epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full-term singleton pregnant women
- American society of anesthesiologist-physical status I or II,
- scheduled for elective cesarean delivery
Key exclusion criteria (6 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,
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 |
|---|---|---|
| Epinephrine 0.03Also: adrenalineepinephrine infusion rate of 0.03 mcg/kg/min | Drug | 0.03 mcg group |
| Epinephrin 0.02Also: adrenalineepinephrine infusion rate of 0.02 mcg/kg/min | Drug | 0.02 mcg group |
| Epinephrin 0.01Also: adrenalineepinephrine infusion rate of 0.01 mcg/kg/min | Drug | 0.01 mcg group |
Primary outcome
incidence of postspinal hypotension
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure ≤80% of the baseline reading
12 secondary outcomes
incidence of tachycardia
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of hypertension
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of severe hypotension
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mean heart rate
Time frame: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mean systolic blood pressure
Time frame: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
total ephedrine requirement
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
total atropine requirement
Time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery
Apgar score
Time frame: 5 minutes after delivery
umbilical blood pH
Time frame: 5 minutes after delivery
umbilical blood PCO2
Time frame: 5 minutes after delivery
umbilical blood PO2
Time frame: 5 minutes after delivery
umbilical blood HCO3
Time frame: 5 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 36858257Hasanin AM, Abou Amer A, Hassabelnaby YS, Mostafa M, Abdelnasser A, Amin SM, Elsherbiny M, Refaat S. The use of epinephrine infusion for the prevention of spinal hypotension during Caesarean delivery: A randomized controlled dose-finding trial. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101204. doi: 10.1016/j.accpm.2023.101204. Epub 2023 Feb 28.
- Individual participant dataSharing planned: No. Available from PI 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.
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 Epinephrine 0.03, Epinephrin 0.02 and Epinephrin 0.01 in people with Postspinal Hypotension and Cesarean Delivery, run by Kasr El Aini Hospital 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 6 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 26 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed hasanin (01095076954, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postspinal hypotension (time frame: 1 minute after subarachnoid injection till 5 minutes after baby delivery). 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 NCT05279703, which also lists 1 linked publication.
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 26 Aug 2022.