Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia
NCT ID: NCT04873596
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
94 participants
INTERVENTIONAL
2021-05-15
2024-08-01
Brief Summary
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Detailed Description
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This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals.
Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.
Nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine.
nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.
Nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam.
Interventions
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Nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine.
Nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild and moderate preeclampsia parturient.
* American Society of AnesthesiologistPhysical status II.
* Body Mass Index (BMI) (25-35kg/m²).
* Type of operations: elective cesarean section under spinal anesthesia.
* Written informed consent from the parturient.
Exclusion Criteria
* Women with known history of allergy to study drugs.
* Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
* Patients receiving anticonvulsants or antidepressants.
* Sever preeclampsia, intrauterine growth restriction or fetal compromise.
21 Years
38 Years
FEMALE
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Alshaimaa Abdel Fattah Kamel
principle investigator
Principal Investigators
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Alshaimaa Kamel, M.D
Role: PRINCIPAL_INVESTIGATOR
Zagazig University, Faculty of human medicine
Locations
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Zagazig University, Faculty of medicine
Zagazig, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6869
Identifier Type: -
Identifier Source: org_study_id
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