Midazolam in Preeclamptic PatientsNCT04283110
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
A study testing intrthecl midazolam in people with Midazolam in Preeclamptic Patients, run by Minia University at 1 site in Egypt.
Trial summary
Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Midazolam in Preeclamptic Patients
- What is being tested?
- intrthecl midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2019to 5 Apr 2020
- 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
- All parturients with severe preeclampsia for urgent C.S
Who cannot join
- Ladies refusal to participate. Refusal to have spinal anesthsia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Elminia university
Cairo, 61511
Hany kamal mikhail, assistant professor, 01223448665, hanykm@yahoo.com
About this study
Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury
- Conditions
- Midazolam in Preeclamptic Patients
- Being tested
- intrthecl midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrthecl midazolamDrug
midazolm as as adjuvant in spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Midazolam group | Active comparator | Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia Receives: Drug: intrthecl midazolam |
| control group | No intervention | control group will receive placebo ( 0.5cm of sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Pulsatality index and resistive index of maternal middle cerebral artery
Resistive vasculer indices outcome after intrthecal midazolam injection
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start12 Jan 2019
- Primary completion17 Feb 2020 (estimated)
- Study completion5 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midazolam in Preeclamptic PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283110
- Sponsor's protocol ID
- 293:9/2019
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data of primary and secondery outcome measures will be avaliable
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
- ClinicalTrials.gov ID
- NCT04283110
- Acronym / sponsor ID
- 293:9/2019
- Conditions
- Midazolam in Preeclamptic Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 17 Feb 2020 (estimated)
- Study completion
- 5 Apr 2020 (estimated)
- First posted
- 25 Feb 2020 (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.
Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam group | Active comparator | Drug: intrthecl midazolamMidazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia |
| control group | No intervention | –control group will receive placebo ( 0.5cm of sterile saline |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All parturients with severe preeclampsia for urgent C.S
Key exclusion criteria (1 listed)
- Ladies refusal to participate. Refusal to have spinal anesthsia
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 |
|---|---|---|
| intrthecl midazolammidazolm as as adjuvant in spinal anesthesia | Drug | Midazolam group |
Primary outcome
Measuring Pulsatality index and resistive index of maternal middle cerebral artery
Time frame: 2 months
Resistive vasculer indices outcome after intrthecal midazolam injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided. All data of primary and secondery outcome measures will be avaliable
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrthecl midazolam in people with Midazolam in Preeclamptic Patients, 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 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Pulsatality index and resistive index of maternal middle cerebral artery (time frame: 2 months). 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 25 Feb 2020.