Postspinal HypotensionPhase 4NCT05290740
Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery
A Phase 4 study testing Norepinephrine 5 mcg and Norepinephrine 10 mcg 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 whose incidence reached 60% in many reports. Hypotension is associated with maternal and neonatal complications; therefore, it is highly recommended to use vasopressors, prophylactically and interactively, for… 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, Norepinephrine
- What is being tested?
- Norepinephrine 5 mcg and Norepinephrine 10 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2022to 25 Jul 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 of 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.
About this study
Official title: Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population whose incidence reached 60% in many reports. Hypotension is associated with maternal and neonatal complications; therefore, it is highly recommended to use vasopressors, prophylactically and interactively, for prompt control maternal blood pressure. Despite the presence of various preventive regimens (fluid loading, maternal positioning, and vasopressors), many mothers develop intraoperative episodes of hypotension which requires the use of a vasopressor bolus.
Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; and is increasingly used in obstetric anesthesia with acceptable maternal and neonatal outcomes. NE bolus could be used for rapid correction of maternal blood pressure in a dose which variedranged between 3.7-10 mcg. Till date, al the available data for the management of maternal hypotension did not differentiate between severe and non-severe hypotension. The incidence of severe maternal hypotension (systolic blood pressure ≤60% of baseline) ranged between 7-20%. In a recent report, Hassabelnaby et al compared 6 mcg and 10 mcg NE boluses in management of maternal hypotension and found that the doses had the same success rate (≈90%); however, most of the participants in the mentioned study had non-severe hypotension. Therefore, we hypothesize that severe hypotension should be separately investigated for the possible superiority of the higher over the lower dose of NE bolus.
Insufficient NE bolus would lead to failed management and prolonged hypotensive episode, whereas a higher dose might lead to reactive hypertension and/or bradycardia, which is sometimes severe. Therefore, determining the optimum dose for NE bolus would enable proper control of maternal hemodynamic profile
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 the supine position with left-lateral tilt. The decision to give prophylactic vasopressor infusion will be according to the attending anesthetist preferences.
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.
The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode or after 10 minutes from the last successfully managed hypotensive episode and before the delivery. .
The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, NE bolus of 5 mcg will be given.
Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with NE bolus of 5 mcg.
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 then infused at a rate of 2.5 IU/hour.
- Conditions
- Postspinal Hypotension, Cesarean Delivery, Norepinephrine
- Being tested
- Norepinephrine 5 mcg, Norepinephrine 10 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine 5 mcgDrug
norepinephrine bolus of 5 mcg for treatment of sever postspinal hypotension
Norepinephrine 10 mcgDrug
norepinephrine bolus of 10 mcg for treatment of sever postspinal hypotension
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Not described Receives: Drug: Norepinephrine 5 mcg |
| group B | Active comparator | Not described Receives: Drug: Norepinephrine 10 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of successful management of severe post-spinal hypotension
systolic blood pressure >80% of baseline within 2 min of drug injection
Measured: 2 minutes after drug injection
Secondary outcomes (6)
time to severe postspinal hypotension
minutes
Measured: 1 minute after subarachnoid local anesthetic injection till 1 min after baby delivery
incidence of reactive bradycardia
heart rate heart rate less than 55 beat per minute
Measured: 2 minutes after drug injection
incidence of reactive hypertension
systolic blood pressure >120% of baseline
Measured: 2 minutes after drug injection
incidence of nausea and vomiting
unpleasant painless subjective feeling that one will imminently vomit or vomiting
Measured: 1 minute after subarachnoid local anesthetic injection till 5 minute after baby delivery
fetal umbilical blood pH
pH
Measured: at 5 minutes post delivery
baby Apgar score
score with 0, 1, or 2, depending on the observed condition.
Measured: at 5 minutes post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start11 Mar 2022
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
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
- NCT05290740
- Sponsor's protocol ID
- MS-657-2021
- Status last verified
- Jun 2023
- First submitted
- 22 Feb 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: protocol and data of this research could be available from the PI upon reasonable request
Publications
Amin SM, Hasanin A, Ghanem NT, Mostafa M, Elzayat N, Elsherbiny M, Abdelwahab Y. Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial. Int J Gen Med. 2024 Jan 19;17:153-160. doi: 10.2147/IJGM.S446021. eCollection 2024.
PubMed 38264276
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05290740
- Acronym / sponsor ID
- MS-657-2021
- Conditions
- Postspinal Hypotension, Cesarean Delivery, Norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 22 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 whose incidence reached 60% in many reports. Hypotension is associated with maternal and neonatal complications; therefore, it is highly recommended to use vasopressors, prophylactically and interactively, for prompt control maternal blood pressure. Despite the presence of various preventive regimens (fluid loading, maternal positioning, and vasopressors), many mothers develop intraoperative episodes of hypotension which requires the use of a vasopressor bolus.
Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; and is increasingly used in obstetric anesthesia with acceptable maternal and neonatal outcomes. NE bolus could be used for rapid correction of maternal blood pressure in a dose which variedranged between 3.7-10 mcg. Till date, al the available data for the management of maternal hypotension did not differentiate between severe and non-severe hypotension. The incidence of severe maternal hypotension (systolic blood pressure ≤60% of baseline) ranged between 7-20%. In a recent report, Hassabelnaby et al compared 6 mcg and 10 mcg NE boluses in management of maternal hypotension and found that the doses had the same success rate (≈90%); however, most of the participants in the mentioned study had non-severe hypotension. Therefore, we hypothesize that severe hypotension should be separately investigated for the possible superiority of the higher over the lower dose of NE bolus.
Insufficient NE bolus would lead to failed management and prolonged hypotensive episode, whereas a higher dose might lead to reactive hypertension and/or bradycardia, which is sometimes severe. Therefore, determining the optimum dose for NE bolus would enable proper control of maternal hemodynamic profile
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 the supine position with left-lateral tilt. The decision to give prophylactic vasopressor infusion will be according to the attending anesthetist preferences.
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.
The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode or after 10 minutes from the last successfully managed hypotensive episode and before the delivery. .
The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, NE bolus of 5 mcg will be given.
Any other hypotensive episode (systolic blood pressure <80% of baseline) will be managed with NE bolus of 5 mcg.
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 then infused at a rate of 2.5 IU/hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Norepinephrine 5 mcg |
| group B | Active comparator | Drug: Norepinephrine 10 mcg |
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 of I or II,
- scheduled for elective cesarean delivery
Key exclusion criteria (5 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, and
- baseline systolic blood pressure (SBP) < 100 mmHg
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 |
|---|---|---|
| Norepinephrine 5 mcgnorepinephrine bolus of 5 mcg for treatment of sever postspinal hypotension | Drug | group A |
| Norepinephrine 10 mcgnorepinephrine bolus of 10 mcg for treatment of sever postspinal hypotension | Drug | group B |
Primary outcome
incidence of successful management of severe post-spinal hypotension
Time frame: 2 minutes after drug injection
systolic blood pressure >80% of baseline within 2 min of drug injection
6 secondary outcomes
time to severe postspinal hypotension
Time frame: 1 minute after subarachnoid local anesthetic injection till 1 min after baby delivery
incidence of reactive bradycardia
Time frame: 2 minutes after drug injection
incidence of reactive hypertension
Time frame: 2 minutes after drug injection
incidence of nausea and vomiting
Time frame: 1 minute after subarachnoid local anesthetic injection till 5 minute after baby delivery
fetal umbilical blood pH
Time frame: at 5 minutes post delivery
baby Apgar score
Time frame: at 5 minutes post delivery
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 18 Jun 2023.
- Derived from this study: PubMed 38264276Amin SM, Hasanin A, Ghanem NT, Mostafa M, Elzayat N, Elsherbiny M, Abdelwahab Y. Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial. Int J Gen Med. 2024 Jan 19;17:153-160. doi: 10.2147/IJGM.S446021. eCollection 2024.
- Individual participant dataSharing planned: No. protocol and data of this research could be available from the 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Norepinephrine 5 mcg and Norepinephrine 10 mcg 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 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 18 Jun 2023. 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 successful management of severe post-spinal hypotension (time frame: 2 minutes after drug injection). 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 NCT05290740, 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 18 Jun 2023.