EphedrineNCT07795710
Intermittent Bolus Doses of Phenylephrine, Norepinephrine and Ephedrine for the Management of Spinal Induced Hypotension in Preeclamptic Patients
A study testing Group 1 (P), Group 2( N) and Group 3( E) in people with Ephedrine and Norepinephrine, run by Minia University at 1 site in Egypt.
Trial summary
intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Ephedrine, Norepinephrine
- What is being tested?
- Group 1 (P), Group 2( N) and Group 3( E)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to 30 Jan 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Preeclamptic pregnant female
- ASA II and III
- singleton or twin pregnancies will be scheduled for caesarean delivery
- diagnosis of preeclampsia as a new onset of hypertension and proteinuria.
Who cannot join
- chronic hypertension, labor or failed trial of labor,
- body mass index ≥40 kg/m2 ,
- resting heart rate <60 bpm, eclampsia,
- known fetal anomalies, contraindications to spinal anesthesia, abruption placentae, and cord prolapas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Intermittent Bolus Doses of Phenylephrine, Norepinephrine and Ephedrine for the Management of Spinal Induced Hypotension in Preeclamptic Patients
intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients
Read the detailed description
A Comparative study of intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients
- Conditions
- Ephedrine, Norepinephrine
- Being tested
- Group 1 (P), Group 2( N), Group 3( E)
- Keywords
- preeclamptic patients, spinal induced hypotension, norepinephrine, ephedrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (P)Drug
receive bolus dose of phenyelepherine 75 ug
Group 2( N)Drug
Group 2( N) will receive bolus dose of noradrenaline 4 ug
Group 3( E)Drug
Group 3( E) will receive bolus dose ephedrine 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (phenyelepherine group) | Experimental | receive bolus dose of phenyelepherine 75 ug Receives: Drug: Group 1 (P) |
| Group 2 ( noradrenaline group) | Experimental | receive bolus dose of noradrenaline 4 ug Receives: Drug: Group 2( N) |
| Group 3 ( ephedrine group) | Experimental | receive bolus dose ephedrine 4 mg Receives: Drug: Group 3( E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate changes
Measured: every 3 minutes till 40 minutes
Secondary outcomes (1)
Systolic blood pressure
Measured: every 3 minutes till 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Jan 2024
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EphedrineStudies of the same condition, open and under way.
- More trials run by Minia 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
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Essam, Minia University
- Investigators
- Ali Ali, Assistant lecturer, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795710
- Sponsor's protocol ID
- 602/2023
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Intermittent Bolus Doses of Phenylephrine, Norepinephrine and Ephedrine for the Management of Spinal Induced Hypotension in Preeclamptic Patients
- ClinicalTrials.gov ID
- NCT07795710
- Acronym / sponsor ID
- 602/2023
- Conditions
- Ephedrine, Norepinephrine
- Keywords
- preeclamptic patients, spinal induced hypotension, norepinephrine, ephedrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 31 Aug 2026 (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.
intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients
Detailed description
A Comparative study of intermittent bolus doses of phenylephrine, norepinephrine and ephedrine for the management of spinal induced hypotension in preeclamptic patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (phenyelepherine group) | Experimental | Drug: Group 1 (P)receive bolus dose of phenyelepherine 75 ug |
| Group 2 ( noradrenaline group) | Experimental | Drug: Group 2( N)receive bolus dose of noradrenaline 4 ug |
| Group 3 ( ephedrine group) | Experimental | Drug: Group 3( E)receive bolus dose ephedrine 4 mg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Preeclamptic pregnant female
- ASA II and III
- singleton or twin pregnancies will be scheduled for caesarean delivery
- diagnosis of preeclampsia as a new onset of hypertension and proteinuria.
Key exclusion criteria (4 listed)
- chronic hypertension, labor or failed trial of labor,
- body mass index ≥40 kg/m2 ,
- resting heart rate <60 bpm, eclampsia,
- known fetal anomalies, contraindications to spinal anesthesia, abruption placentae, and cord prolapas.
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 |
|---|---|---|
| Group 1 (P)receive bolus dose of phenyelepherine 75 ug | Drug | Group 1 (phenyelepherine group) |
| Group 2( N)Group 2( N) will receive bolus dose of noradrenaline 4 ug | Drug | Group 2 ( noradrenaline group) |
| Group 3( E)Group 3( E) will receive bolus dose ephedrine 4 mg | Drug | Group 3 ( ephedrine group) |
Primary outcome
Heart rate changes
Time frame: every 3 minutes till 40 minutes
1 secondary outcome
Systolic blood pressure
Time frame: every 3 minutes till 40 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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
Related trials for Ephedrine
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease
Not yet recruitingObservational study
Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
Hypotension, Nausea
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
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.
Ali Ali, Assistant lecturer principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (P), Group 2( N) and Group 3( E) in people with Ephedrine and Norepinephrine, run by Minia 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 4 inclusion and 4 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 31 Aug 2026. 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?
Heart rate changes (time frame: every 3 minutes till 40 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 31 Aug 2026.