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

NCT ID: NCT04283110

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2020-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Midazolam in Preeclamptic Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Midazolam group

Midazolam group will receive 1 mg intrathecal midazolam once during induction for anethesia

Group Type ACTIVE_COMPARATOR

intrthecl midazolam

Intervention Type DRUG

midazolm as as adjuvant in spinal anesthesia

control group

control group will receive placebo ( 0.5cm of sterile saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intrthecl midazolam

midazolm as as adjuvant in spinal anesthesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All parturients with severe preeclampsia for urgent C.S

Exclusion Criteria

* Ladies refusal to participate. Refusal to have spinal anesthsia
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mina Maher

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Elminia university

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hany kamal mikhail, assistant professor

Role: primary

01223448665

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

293:9/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sedation During Spinal Anesthesia
NCT03133780 COMPLETED PHASE2