Back to resultsImpact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
Primary Purpose
Midazolam in Preeclamptic Patients
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intrthecl midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Midazolam in Preeclamptic Patients
Eligibility Criteria
Inclusion Criteria:
- All parturients with severe preeclampsia for urgent C.S
Exclusion Criteria:
- Ladies refusal to participate. Refusal to have spinal anesthsia
Sites / Locations
- Elminia universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Midazolam group
control group
Arm Description
Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia
control group will receive placebo ( 0.5cm of sterile saline
Outcomes
Primary Outcome Measures
Measuring Pulsatality index and resistive index of maternal middle cerebral artery
Resistive vasculer indices outcome after intrthecal midazolam injection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04283110
Brief Title
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
February 17, 2020 (Anticipated)
Study Completion Date
April 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Midazolam in Preeclamptic Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midazolam group
Arm Type
Active Comparator
Arm Description
Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group will receive placebo ( 0.5cm of sterile saline
Intervention Type
Drug
Intervention Name(s)
intrthecl midazolam
Intervention Description
midazolm as as adjuvant in spinal anesthesia
Primary Outcome Measure Information:
Title
Measuring Pulsatality index and resistive index of maternal middle cerebral artery
Description
Resistive vasculer indices outcome after intrthecal midazolam injection
Time Frame
2 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
All cases are ladies with severe preeclampsia
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All parturients with severe preeclampsia for urgent C.S
Exclusion Criteria:
Ladies refusal to participate. Refusal to have spinal anesthsia
Facility Information:
Facility Name
Elminia university
City
Cairo
ZIP/Postal Code
61511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany kamal mikhail, assistant professor
Phone
01223448665
Email
hanykm@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
All data of primary and secondery outcome measures will be avaliable
Learn more about this trial
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
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