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Search / Trial NCT04873596

Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia

Launched by ZAGAZIG UNIVERSITY · Apr 29, 2021

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different medications, dexmedetomidine and midazolam, when given as a mist (nebulization) to help women relax during a cesarean delivery. The aim is to find out if one medication is better than the other for women who have mild to moderate pre-eclampsia, a condition that can occur during pregnancy and affects blood pressure.

To be eligible for this study, women must be between 21 and 38 years old, have a body mass index (BMI) between 25 and 35, and be planning to have an elective cesarean section under spinal anesthesia. It's important that participants do not have certain medical issues, such as severe pre-eclampsia or allergies to the study drugs, as these could affect their safety or the results of the trial. Those who join the study will receive one of the two medications and will be monitored throughout the procedure to see how well they work for sedation. This trial is currently seeking volunteers, so it’s a good opportunity for eligible women who want to contribute to research in this area.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Zagazig University

Zagazig University, a prominent educational and research institution located in Egypt, plays a pivotal role in advancing medical knowledge and promoting health innovations through its clinical trials. With a commitment to excellence in research, the university leverages its diverse expertise and state-of-the-art facilities to conduct rigorous clinical studies that aim to improve patient care and outcomes. By fostering collaboration among multidisciplinary teams, Zagazig University contributes significantly to the global medical community, ensuring that its clinical trials adhere to the highest ethical standards and regulatory requirements.

Locations

Zagazig, , Egypt

Patients applied

0 patients applied

Trial Officials

Alshaimaa Kamel, M.D

Principal Investigator

Zagazig University, Faculty of human medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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