Cesarean Section ComplicationsPhase 4NCT03792906
Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery
A Phase 4 study testing Norepinephrine 6 mcg, Norepinephrine 10 mcg and Norepinephrine infusion in people with Cesarean Section Complications and Spinal Anesthetic Toxicity, run by Cairo University at 1 site in Egypt.
Trial summary
In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications, Spinal Anesthetic Toxicity
- What is being tested?
- Norepinephrine 6 mcg, Norepinephrine 10 mcg and Norepinephrine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2019to 1 May 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- Scheduled for cesarean delivery
Who cannot join
- Patients with severe cardiac dysfunction
- Patients with low blood pressure
- Patients with ante-partum bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses
In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.
Read the detailed description
Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .
The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .
Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.
No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.
- Being tested
- Norepinephrine 6 mcg, Norepinephrine 10 mcg, Norepinephrine infusion, Bupivacaine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine 6 mcgDrug
Also called Levophed
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
Norepinephrine 10 mcgDrug
Also called Levophed
An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
Norepinephrine infusionDrug
Also called Levophed
Prophylactic norepinephrine infusion will be started after subarachnoid block.
Bupivacaine hydrochlorideDrug
Also called marcaine
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine 6 mcg | Experimental | Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion Receives: Drug: Norepinephrine 6 mcg; Drug: Norepinephrine infusion; Drug: Bupivacaine hydrochloride |
| Norepinephrine 10 mcg | Active comparator | Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion. Receives: Drug: Norepinephrine 10 mcg; Drug: Norepinephrine infusion; Drug: Bupivacaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful management of maternal hypotension
number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (8)
Rate of successful management of severe maternal hypotension.
number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
Measured: 30 minutes after spinal anesthesia
Incidence of reactive hypertension
number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).
Measured: 30 minutes after spinal anesthesia
Systolic blood pressure.
Systolic blood pressure measured in mmHg.
Measured: 2 hours after subarachnoid block
Heart rate
Number of heart beats per minute.
Measured: 2 hours after subarachnoid block
Apgar score for evaluation of the activity of the fetus
the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10.
Measured: 10 minutes
Umbilical blood acidity
the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.
Measured: 10 minutes after delivery
The frequency of vomiting.
The number of patients with vomiting.
Measured: 2 hours after subarachnoid block
Incidence of bradycardia
number of patients with bradycardia (defined as heart rate less than 55 beat per minute after administration of norepinephrine bolus).
Measured: 2 hours after subarachnoid block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Jan 2019
- Primary completion25 Apr 2019
- Study completion1 May 2019
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 Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed M Hasanin, Professor, Principal investigator, Assistant professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792906
- Sponsor's protocol ID
- N71-2018
- Status last verified
- Sep 2021
- First submitted
- 2 Jan 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32303180
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses
- ClinicalTrials.gov ID
- NCT03792906
- Acronym / sponsor ID
- N71-2018
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 4 Jan 2019 (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.
In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.
Detailed description
Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .
The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .
Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.
No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.
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 |
|---|---|---|
| Norepinephrine 6 mcg | Experimental | Drug: Norepinephrine 6 mcg, Drug: Norepinephrine infusion, Drug: Bupivacaine hydrochlorideMothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion |
| Norepinephrine 10 mcg | Active comparator | Drug: Norepinephrine 10 mcg, Drug: Norepinephrine infusion, Drug: Bupivacaine hydrochlorideMothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women
- Scheduled for cesarean delivery
Key exclusion criteria (3 listed)
- Patients with severe cardiac dysfunction
- Patients with low blood pressure
- Patients with ante-partum bleeding
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 6 mcgAlso: LevophedAn intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension. | Drug | Norepinephrine 6 mcg |
| Norepinephrine 10 mcgAlso: LevophedAn intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension. | Drug | Norepinephrine 10 mcg |
| Norepinephrine infusionAlso: LevophedProphylactic norepinephrine infusion will be started after subarachnoid block. | Drug | Norepinephrine 10 mcg, Norepinephrine 6 mcg |
| Bupivacaine hydrochlorideAlso: marcaineSubarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg. | Drug | Norepinephrine 10 mcg, Norepinephrine 6 mcg |
Primary outcome
Rate of successful management of maternal hypotension
Time frame: 30 minutes after spinal anesthesia
number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).
8 secondary outcomes
Rate of successful management of severe maternal hypotension.
Time frame: 30 minutes after spinal anesthesia
Incidence of reactive hypertension
Time frame: 30 minutes after spinal anesthesia
Systolic blood pressure.
Time frame: 2 hours after subarachnoid block
Heart rate
Time frame: 2 hours after subarachnoid block
Apgar score for evaluation of the activity of the fetus
Time frame: 10 minutes
Umbilical blood acidity
Time frame: 10 minutes after delivery
The frequency of vomiting.
Time frame: 2 hours after subarachnoid block
Incidence of bradycardia
Time frame: 2 hours after subarachnoid block
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 24 Sep 2021.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
Ahmed M Hasanin, Professor principal investigator
Assistant professor of anesthesia
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 6 mcg, Norepinephrine 10 mcg and Norepinephrine infusion in people with Cesarean Section Complications and Spinal Anesthetic Toxicity, run by Cairo University 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 3 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 24 Sep 2021. 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?
Rate of successful management of maternal hypotension (time frame: 30 minutes after spinal anesthesia). 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 NCT03792906, 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 24 Sep 2021.