NCT04873596

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

Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: 21 Years – 38 Years
• Healthy volunteers: Accepted

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 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

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 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

• Procedural Sedation

Interventions

Type	Name	Description
DRUG	Nebulized dexmedetomidine	parturient will receive nebulized 3ug/kg dexmedetomidine.
DRUG	Nebulized midazolam	parturient will receive nebulized 0.2 mg/kg midazolam.

Timeline

• Start date: 2021-05-15
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2021-05-05
• Last updated: 2024-03-01

Locations

1 site across 1 country: Egypt