Perioperative InfusionNCT07067944
Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia
A study testing Ephedrine and Noradrenaline in people with Perioperative Infusion and Ephedrine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Perioperative Infusion, Ephedrine, Noradrenaline
- What is being tested?
- Ephedrine and Noradrenaline
- 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 Jul 2023to 1 Mar 2024
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 21 years.
- American Society of Anesthesiologists Physical Status II and III.
- Full-term singleton pregnant women scheduled for elective cesarean section under spinal anesthesia.
Who cannot join
- Morbid obesity [body mass index (BMI)>40].
- Diabetes Mellitus.
- Severe cardiovascular disease.
- Hypertensive disorders of pregnancy.
- Chronic kidney disease.
- Non-assuring fetal status.
- Peripartum bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Preventive Role of Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized, Prospective Double-blinded Study
This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries.
Read the detailed description
Neuraxial anesthesia for cesarean delivery (CD) has significantly reduced maternal mortality by avoiding Manipulation of the airway, the mother being awake, and promoting early bonding of mother and child, adequate Postoperative analgesia, and quicker maternal recovery.
Systemic vascular resistance decreases as a result of a reduction in sympathetic tone of the arterial circulation, leading to peripheral arterial vasodilation, the extent of which depends on the number of spinal segments involved. Other theories are proposed to explain hypotension during spinal anesthesia, among them: 1)direct depressive circulatory effect of local anesthetics, 2) relative adrenal insufficiency, 3) skeletal muscle paralysis, 4) ascending medullary vasomotor block, and 5) concurrent mechanical respiratory insufficiency. Loss of sympathetic input to the heart, leaving vagal parasympathetic innervations unopposed, and a decrease in cardiac preload are the main reasons for bradycardia during spinal anesthesia.
- Being tested
- Ephedrine, Noradrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.
NoradrenalineDrug
The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min. Receives: Drug: Ephedrine |
| Group B | Experimental | The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute. Receives: Drug: Noradrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal systolic blood pressure
Maternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.
Measured: 10 minutes after induction of spinal anesthesia
Secondary outcomes (4)
Heart rate
Intraoperative heart rate was recorded after spinal anesthesia induction.
Measured: Intraoperatively
Number of needed rescue boluses of vasopressors
Number of needed rescue boluses of vasopressors to keep hemodynamic stability after spinal anesthesia induction.
Measured: After induction of spinal anesthesia (Up to 2 hours)
Incidence of adverse events
Incidence of adverse events such as nausea and vomiting were recorded.
Measured: 2 hours after induction of spinal anesthesia
APGAR score
APGAR score was recorded at 1 and 5 minutes after delivery.
Measured: 5 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 posted16 Jul 2025
- Study start1 Jul 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative InfusionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Gamal Fouda, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067944
- Sponsor's protocol ID
- 36264MS146/4/23
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Role of Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized, Prospective Double-blinded Study
- ClinicalTrials.gov ID
- NCT07067944
- Acronym / sponsor ID
- 36264MS146/4/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Jul 2025 (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.
This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries.
Detailed description
Neuraxial anesthesia for cesarean delivery (CD) has significantly reduced maternal mortality by avoiding Manipulation of the airway, the mother being awake, and promoting early bonding of mother and child, adequate Postoperative analgesia, and quicker maternal recovery.
Systemic vascular resistance decreases as a result of a reduction in sympathetic tone of the arterial circulation, leading to peripheral arterial vasodilation, the extent of which depends on the number of spinal segments involved. Other theories are proposed to explain hypotension during spinal anesthesia, among them: 1)direct depressive circulatory effect of local anesthetics, 2) relative adrenal insufficiency, 3) skeletal muscle paralysis, 4) ascending medullary vasomotor block, and 5) concurrent mechanical respiratory insufficiency. Loss of sympathetic input to the heart, leaving vagal parasympathetic innervations unopposed, and a decrease in cardiac preload are the main reasons for bradycardia during spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: EphedrineThe parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min. |
| Group B | Experimental | Drug: NoradrenalineThe parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 21 years.
- American Society of Anesthesiologists Physical Status II and III.
- Full-term singleton pregnant women scheduled for elective cesarean section under spinal anesthesia.
Key exclusion criteria (7 listed)
- Morbid obesity [body mass index (BMI)>40].
- Diabetes Mellitus.
- Severe cardiovascular disease.
- Hypertensive disorders of pregnancy.
- Chronic kidney disease.
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 |
|---|---|---|
| EphedrineThe parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min. | Drug | Group A |
| NoradrenalineThe parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute. | Drug | Group B |
Primary outcome
Maternal systolic blood pressure
Time frame: 10 minutes after induction of spinal anesthesia
Maternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.
4 secondary outcomes
Heart rate
Time frame: Intraoperatively
Number of needed rescue boluses of vasopressors
Time frame: After induction of spinal anesthesia (Up to 2 hours)
Incidence of adverse events
Time frame: 2 hours after induction of spinal anesthesia
APGAR score
Time frame: 5 minutes after 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 16 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 study testing Ephedrine and Noradrenaline in people with Perioperative Infusion and Ephedrine, run by Tanta 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 3 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: finished, as of the sponsor's last update on 16 Jul 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?
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?
Maternal systolic blood pressure (time frame: 10 minutes after induction of spinal anesthesia). 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 16 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.