HypotensionNCT04367103
Norepinephrine for Hypotension in Cesarean Section
A study testing Norepinephrine and Phenylephrine in people with Hypotension and Cesarean Section, run by Assiut University at 1 site in Egypt.
Trial summary
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Cesarean Section
- What is being tested?
- Norepinephrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 4 May 2022
- Phase
- Interventional
- 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
- Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.
Who cannot join
- Patient refusal either to study enrollment or to spinal anesthesia.
- Any absolute contraindication to spinal anesthesia e.g. coagulopathy, skin infection at site of injection.
- Allergy to any of study drugs.
- Patients with cardiac morbidities, hypertensive disorders or peripartum bleeding
- BMI > 40 kg/m²
- Baseline systolic blood pressure < 100 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.
Read the detailed description
Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.
- Conditions
- Hypotension, Cesarean Section
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- post 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.
NorepinephrineDrug
Also called noradrenaline
prophylaxis for hypotension
PhenylephrineDrug
Also called phenylephrine hydrochloride
standerd prophylaxis for hypotension
| Study group | Role | What they receive |
|---|---|---|
| NEP group | Active comparator | Norepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline. Receives: Drug: Norepinephrine |
| PHE group | Placebo comparator | Phenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate. Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotensive episodes.
Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.
Measured: 15-20 minutes
Secondary outcomes (4)
Incidence of maternal bradycardia.
Bradycardia is defined as heart rate (HR) < 50 beats/min
Measured: 15-20 minutes
Incidence of reactive hypertension
defined as >120% of baseline.
Measured: 20 minutes
nausea and vomiting
Incidence of nausea and vomiting attacks.
Measured: 20 minutes
Total dose of vasopressor
Total dose of vasopressor used.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start10 Apr 2021
- Primary completion4 May 2022
- Study completion4 May 2022
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.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abbas Hassan, Assiut University
- Investigators
- Mohamed M. Abdellatif, M.D., Study director, Assiut UniversityShimaa A. Husien, M.D., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367103
- Sponsor's protocol ID
- ShA
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2020
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine or Phenylephrine for Hypotension in Non-elective Cesarean Section
- ClinicalTrials.gov ID
- NCT04367103
- Acronym / sponsor ID
- ShA
- Conditions
- Hypotension, Cesarean Section
- Keywords
- post spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 29 Apr 2020 (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.
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.
Detailed description
Phenylephrine has a potent direct α effect, with virtually no β effects at clinical doses, however when given at higher than required doses, it may induce baroreceptor-mediated bradycardia with a consequent reduction in maternal cardiac output. Although α agonist drugs are the most appropriate agents to treat or prevent hypotension following spinal anaesthesia, those with a small amount of β agonist activity may have the best profile (noradrenaline (norepinephrine) and metaraminol. Phenylephrine is currently recommended due to the amount of supporting data.Noradrenaline is the primary catecholamine released by postganglionic adrenergic nerves. It is a potent α adrenergic agonist, with comparatively modest β agonist activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEP group | Active comparator | Drug: NorepinephrineNorepinephrine infusion of 0.025 µg/kg/min and 6 µg bolus will be used if BP is reduced 20 % below baseline. |
| PHE group | Placebo comparator | Drug: PhenylephrinePhenylephrine will be started at 25µg/min immediately after the intrathecal local anaesthetic injection and titrated according to blood pressure and pulse rate. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who fall in category 2 and 3 according to the classification of Caesarean section made by Royal College of Obstetrician and Gynaecologists.
Key exclusion criteria (6 listed)
- Patient refusal either to study enrollment or to spinal 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 |
|---|---|---|
| NorepinephrineAlso: noradrenalineprophylaxis for hypotension | Drug | NEP group |
| PhenylephrineAlso: phenylephrine hydrochloridestanderd prophylaxis for hypotension | Drug | PHE group |
Primary outcome
Incidence of hypotensive episodes.
Time frame: 15-20 minutes
Hypotension is defined as <80% of baseline or systolic blood pressure (SBP) <100 mmHg.
4 secondary outcomes
Incidence of maternal bradycardia.
Time frame: 15-20 minutes
Incidence of reactive hypertension
Time frame: 20 minutes
nausea and vomiting
Time frame: 20 minutes
Total dose of vasopressor
Time frame: 20 minutes
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 4 Jan 2023.
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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 M. Abdellatif, M.D. study director
Assiut University
Shimaa A. Husien, M.D. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Phenylephrine in people with Hypotension and Cesarean Section, run by Assiut 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 1 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: finished, as of the sponsor's last update on 4 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 hypotensive episodes. (time frame: 15-20 minutes). 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 4 Jan 2023.