Anesthesia; Adverse EffectPhase 4NCT05368415
Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
A Phase 4 study testing Norepinephrine in people with Anesthesia; Adverse Effect and Cesarean Section Complications, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Cesarean Section Complications
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2022to 15 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
- pregnant female with preeclampsia
- age 18-40
Who cannot join
- age less than 18
- age above 40
- patient refusal of spinal anesthesia
- patient with eclampsia
- patient allergy to anesthesia drugs or to NE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .
The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.
- Being tested
- Norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called levophed
mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation
| Study group | Role | What they receive |
|---|---|---|
| 3 mcg grup | Active comparator | this group will receive Norepinephrine bolus of 3 mcg for management of hypotension. Receives: Drug: Norepinephrine |
| 4 mcg group | Active comparator | this group will receive Norepinephrine bolus of 4 mcg for management of hypotension Receives: Drug: Norepinephrine |
| 5 mcg group | Active comparator | this group will receive Norepinephrine bolus of 5 mcg for management of hypotension Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome
measuring HCO3 from umbilical cord blood gases analysis
Measured: up to 5 minutes after delivery
Secondary outcomes (1)
Rate of successful management of maternal hypotension
defined as returned of SBP to be > 80% of the baseline reading in the next reading 2 minutes after administration of NE bolus
Measured: 2 minutes after NE bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 May 2022
- Primary completion1 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Arafa, Kasr El Aini Hospital
- Investigators
- Mohamed S Arafa, MD, Principal investigator, Lecturer of anesthesia and surgical ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368415
- Sponsor's protocol ID
- Levo bolus in CS
- Status last verified
- Aug 2022
- First submitted
- 6 May 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Publications
Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y.
PubMed 32303180Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.
PubMed 30935897
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT05368415
- Acronym / sponsor ID
- Levo bolus in CS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 10 May 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 subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .
The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 mcg grup | Active comparator | Drug: Norepinephrinethis group will receive Norepinephrine bolus of 3 mcg for management of hypotension. |
| 4 mcg group | Active comparator | Drug: Norepinephrinethis group will receive Norepinephrine bolus of 4 mcg for management of hypotension |
| 5 mcg group | Active comparator | Drug: Norepinephrinethis group will receive Norepinephrine bolus of 5 mcg for management of hypotension |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant female with preeclampsia
- age 18-40
Key exclusion criteria (5 listed)
- age less than 18
- age above 40
- patient refusal of spinal anesthesia
- patient with eclampsia
- patient allergy to anesthesia drugs or to NE
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 |
|---|---|---|
| NorepinephrineAlso: levophedmothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation | Drug | 3 mcg grup, 4 mcg group, 5 mcg group |
Primary outcome
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome
Time frame: up to 5 minutes after delivery
measuring HCO3 from umbilical cord blood gases analysis
1 secondary outcome
Rate of successful management of maternal hypotension
Time frame: 2 minutes after NE bolus
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 Aug 2022.
- Background: PubMed 32303180Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y.
- Background: PubMed 30935897Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.
- Individual participant dataSharing planned: Yes. 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.
Mohamed S Arafa, MD principal investigator
Lecturer of anesthesia and surgical ICU
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 in people with Anesthesia; Adverse Effect and Cesarean Section Complications, 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 2 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 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?
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?
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome (time frame: up to 5 minutes after 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 NCT05368415, which also lists 2 linked publications.
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 Aug 2022.