Status:
RECRUITING
Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia
Lead Sponsor:
Zagazig University
Conditions:
Procedural Sedation
Eligibility:
FEMALE
21-38 years
Phase:
PHASE2
Brief Summary
Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic pa...
Detailed Description
Site of study: 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 ...
Eligibility Criteria
Inclusion
- Age: 21-38 years old.
- 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
- Altered mental state.
- 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.
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04873596
Start Date
May 15 2021
End Date
August 1 2024
Last Update
March 1 2024
Active Locations (1)
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1
Zagazig University, Faculty of medicine
Zagazig, Egypt