Comparing Ephedrine With Norepinephrine for Mangement Postspinal HypotensionNCT05522088
Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension
An observational study of Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension, run by Wachemo University at 1 site in Ethiopia.
Trial summary
This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension
- How many people
- 84 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Mar 2022to 30 Apr 2022
- Phase
- Observational
- 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 35 years
- Women only
- Adult
Study population: All pregnant women undergoing elective cesarean section fulfills the inclusion criteria were the source population
Who may be able to join
- ASA class II and ages ranging from 18-35 years were included in the study
Who cannot join
- pregnant women with preeclampsia/eclampsia, baseline hypertension (SBP> 140 mm Hg), BMI> 30 kg/m2, failed spinal, spinal anaesthesia converted to general anaesthesia, contraindication for spinal anaesthesia and mother with cardiovascular, renal or hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension During Elective Caesarean Section in Resource Limited Setting: a Prospective Cohort Study
This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare mean blood pressure (MAP) between the groups
Measured: From March,01 to April, 30/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Mar 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparing Ephedrine With Norepinephrine for Mangement Postspinal HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wachemo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitiku Desalegn, Wachemo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522088
- Sponsor's protocol ID
- NE2323
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
Publications
Desalegn M, Shitemaw T, Tamrat H. Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Postspinal Hypotension during Elective Caesarean Section in Resource Limited Setting: A Prospective Cohort Study. Anesthesiol Res Pract. 2022 Oct 3;2022:7170301. doi: 10.1155/2022/7170301. eCollection 2022.
PubMed 36225250
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension During Elective Caesarean Section in Resource Limited Setting: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05522088
- Acronym / sponsor ID
- NE2323
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Wachemo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Aug 2022 (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 was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All pregnant women undergoing elective cesarean section fulfills the inclusion criteria were the source population
Key inclusion criteria (1 listed)
- ASA class II and ages ranging from 18-35 years were included in the study
Key exclusion criteria (1 listed)
- pregnant women with preeclampsia/eclampsia, baseline hypertension (SBP> 140 mm Hg), BMI> 30 kg/m2, failed spinal, spinal anaesthesia converted to general anaesthesia, contraindication for spinal anaesthesia and mother with cardiovascular, renal or hepatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to compare mean blood pressure (MAP) between the groups
Time frame: From March,01 to April, 30/2022
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 30 Aug 2022.
- Derived from this study: PubMed 36225250Desalegn M, Shitemaw T, Tamrat H. Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Postspinal Hypotension during Elective Caesarean Section in Resource Limited Setting: A Prospective Cohort Study. Anesthesiol Res Pract. 2022 Oct 3;2022:7170301. doi: 10.1155/2022/7170301. eCollection 2022.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
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?
An observational study of Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension, run by Wachemo University at 1 site in Ethiopia.
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 1 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 30 Aug 2022. 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 Ethiopia. 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?
to compare mean blood pressure (MAP) between the groups (time frame: From March,01 to April, 30/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522088, which also lists 1 linked publication.
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 30 Aug 2022.