Cesarean SectionNCT06102382
The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
A study testing Norepinephrine (0.1) and Norepinephrine (0.075) in people with Cesarean Section and Hypotension, run by Assiut University at 1 site in Egypt.
Trial summary
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Hypotension, Norepinephrine
- What is being tested?
- Norepinephrine (0.1) and Norepinephrine (0.075)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women scheduled for cesarean section under spinal anesthesia
- Gestational age of at least 37 weeks
Who cannot join
- Patient refusal
- Contraindications of spinal anesthesia
- Allergy to the study drug
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- patients with cardiac morbidities
- Hypertensive disorders of pregnancy.
- Prepartum hemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Woman Health Hospital
Asyut
Zakaria Ah. Zakaria, za6841924@gmail.com
Hany M. Osman, M.D., hanymeo@aun.edu.eg
About this study
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
Read the detailed description
Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.
Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.
Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.
The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
- Conditions
- Cesarean Section, Hypotension, Norepinephrine
- Being tested
- Norepinephrine (0.1), Norepinephrine (0.075)
- Keywords
- Norepinephrine, Spinal anesthesia, Hypotension, Cesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine (0.1)Drug
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
Norepinephrine (0.075)Drug
An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine (0.1) | Experimental | An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus. Receives: Drug: Norepinephrine (0.1) |
| Norepinephrine (0.075) | Active comparator | An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus. Receives: Drug: Norepinephrine (0.075) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of post-spinal hypotension
Measured: During the first hour after the subarachnoid block
Secondary outcomes (4)
Arterial blood pressure (Systolic, diastolic, and mean)
Measured: During the first hour after the subarachnoid block
Heart rate
Measured: During the first hour after the subarachnoid block
Doses of atropine and ephedrine
Measured: Intraoperative
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Ranges from 0 (the worst score) to 10 (the best score)
Measured: 1, 5, and 10 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 posted26 Oct 2023
- Study start1 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakaria Ahmed Zakaria, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102382
- Sponsor's protocol ID
- Noradrenaline in CS under SA
- Status last verified
- Aug 2025
- First submitted
- 21 Oct 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
- ClinicalTrials.gov ID
- NCT06102382
- Acronym / sponsor ID
- Noradrenaline in CS under SA
- Conditions
- Cesarean Section, Hypotension, Norepinephrine
- Keywords
- Norepinephrine, Spinal anesthesia, Hypotension, Cesarean section
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.
Detailed description
Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.
Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.
Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.
The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean 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 (0.1) | Experimental | Drug: Norepinephrine (0.1)An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus. |
| Norepinephrine (0.075) | Active comparator | Drug: Norepinephrine (0.075)An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women scheduled for cesarean section under spinal anesthesia
- Gestational age of at least 37 weeks
Key exclusion criteria (7 listed)
- Patient refusal
- Contraindications of spinal anesthesia
- Allergy to the study drug
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- patients with cardiac morbidities
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 (0.1)An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus. | Drug | Norepinephrine (0.1) |
| Norepinephrine (0.075)An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus. | Drug | Norepinephrine (0.075) |
Primary outcome
The frequency of post-spinal hypotension
Time frame: During the first hour after the subarachnoid block
4 secondary outcomes
Arterial blood pressure (Systolic, diastolic, and mean)
Time frame: During the first hour after the subarachnoid block
Heart rate
Time frame: During the first hour after the subarachnoid block
Doses of atropine and ephedrine
Time frame: Intraoperative
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score
Time frame: 1, 5, and 10 minutes after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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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.
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 (0.1) and Norepinephrine (0.075) in people with Cesarean Section and Hypotension, 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zakaria A. Zakaria (+201150637566, za6841924@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of post-spinal hypotension (time frame: During the first hour after the subarachnoid block). 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 29 Aug 2025.