Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia

February 21, 2020 updated by: Mina Maher, Minia University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 61511
        • Recruiting
        • ElMinia University
        • Contact:
          • Hany kamal mikhail, assistant professor
          • Phone Number: 01223448665
          • Email: hanykm@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All parturients with severe preeclampsia for urgent C.S

Exclusion Criteria:

  • Ladies refusal to participate. Refusal to have spinal anesthsia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Midazolam group
Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia
Drug: intrthecl midazolam
midazolm as as adjuvant in spinal anesthesia
NO_INTERVENTION: control group
control group will receive placebo ( 0.5cm of sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Pulsatality index and resistive index of maternal middle cerebral artery
Time Frame: 2 months
Resistive vasculer indices outcome after intrthecal midazolam injection
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2019

Primary Completion (ANTICIPATED)

February 17, 2020

Study Completion (ANTICIPATED)

April 5, 2020

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 293:9/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data of primary and secondery outcome measures will be avaliable

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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