AnesthesiaPhase 4NCT05993182
Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.
A Phase 4 study testing Ephedrine 5mg, Ephedrine 10mg and Ephedrine 15mg in people with Anesthesia and Cesarean Section Complications, run by Aswan University at 1 site in Egypt.
Trial summary
compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Anesthesia, Cesarean Section Complications, Subarachnoid Block
- What is being tested?
- Ephedrine 5mg, Ephedrine 10mg and Ephedrine 15mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2023to 1 Jan 2024
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists 1 and 2 patients
- Gestational amenorrhea of > 32 weeks
- Elective cesarean section
- Patient willing for spinal anesthesia.
- Singleton pregnancy with cephalic presentation.
- Baseline systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 70-89 mmHg.
Who cannot join
- Any contraindication to spinal anesthesia, i.e., local infection at the site of injection
- valvular heat diseases
- bleeding tendency
- any co-morbidity like diabetes mellitus
- liver cirrhosis
- renal failure
Show all 13Show fewer
- any obstetric complications like placenta previa
- pregnancy-induced hypertension or HELLP syndrome
- multiple gestations
- fetal malformation
- coagulopathies
- morbid obesity and spine deformity
- profound hypotension (total spinal) bradycardia and need atropine and severe bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.
compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg
Read the detailed description
In cesarean section, under subarachnoid block the most common complication is hypotension with a reported incidence greater than 80%. Hypotension may occur even after left uterine displacement and preloading with crystalloid. The severity of hypotension depends on the degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of local anesthetic drugs administered. The most effective treatment of hypotension associated with cesarean section under subarachnoid block is the administration of vasopressor drugs.
- Being tested
- Ephedrine 5mg, Ephedrine 10mg, Ephedrine 15mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ephedrine 5mgDrug
Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
Ephedrine 10mgDrug
Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
Ephedrine 15mgDrug
Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
| Study group | Role | What they receive |
|---|---|---|
| Group-I | Active comparator | received 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] Receives: Drug: Ephedrine 5mg |
| Group-II | Active comparator | received 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] Receives: Drug: Ephedrine 10mg |
| Group-III | Active comparator | 15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension] Receives: Drug: Ephedrine 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival analysis or time until an event occurs
The study time is a30 minute and blood pressure is measured automatically non invasive at 3-minute intervals. If systolic blood pressure decreased more than 20% from the baseline(Event)
Measured: Intraoperatively
Secondary outcomes (2)
Starting point or Base line time
Starting point or Base line time is a first hypotension
Measured: Intraoperatively
Survival time
Free of event(No hypotension) at any time after base line
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start20 Aug 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamady Eldemrdash, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993182
- Sponsor's protocol ID
- 669/10/22
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.
- ClinicalTrials.gov ID
- NCT05993182
- Acronym / sponsor ID
- 669/10/22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 15 Aug 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.
compare the time of second hypotension after administration of three different doses of ephedrine 5,10,15 mg
Detailed description
In cesarean section, under subarachnoid block the most common complication is hypotension with a reported incidence greater than 80%. Hypotension may occur even after left uterine displacement and preloading with crystalloid. The severity of hypotension depends on the degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of local anesthetic drugs administered. The most effective treatment of hypotension associated with cesarean section under subarachnoid block is the administration of vasopressor drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-I | Active comparator | Drug: Ephedrine 5mgreceived 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] |
| Group-II | Active comparator | Drug: Ephedrine 10mgreceived 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension] |
| Group-III | Active comparator | Drug: Ephedrine 15mg15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension] |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists 1 and 2 patients
- Gestational amenorrhea of > 32 weeks
- Elective cesarean section
- Patient willing for spinal anesthesia.
- Singleton pregnancy with cephalic presentation.
Key exclusion criteria (13 listed)
- Any contraindication to spinal anesthesia, i.e., local infection at the site of injection
- valvular heat diseases
- bleeding tendency
- any co-morbidity like diabetes mellitus
- liver cirrhosis
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 |
|---|---|---|
| Ephedrine 5mgPatients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension] | Drug | Group-I |
| Ephedrine 10mgPatients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension] | Drug | Group-II |
| Ephedrine 15mgPatients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension] | Drug | Group-III |
Primary outcome
Survival analysis or time until an event occurs
Time frame: Intraoperatively
The study time is a30 minute and blood pressure is measured automatically non invasive at 3-minute intervals. If systolic blood pressure decreased more than 20% from the baseline(Event)
2 secondary outcomes
Starting point or Base line time
Time frame: Intraoperatively
Survival time
Time frame: Intraoperatively
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 1 Mar 2024.
- 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 Phase 4 study testing Ephedrine 5mg, Ephedrine 10mg and Ephedrine 15mg in people with Anesthesia and Cesarean Section Complications, run by Aswan 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 6 inclusion and 13 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 1 Mar 2024. 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?
Survival analysis or time until an event occurs (time frame: Intraoperatively). 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 1 Mar 2024.