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

Recruiting
21 - 38 years of age
Female
Phase 2

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Overview

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 parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients

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 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.

Eligibility

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.

Study details

Procedural Sedation

NCT04873596

Zagazig University

7 March 2024

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