Using nebulized dexmedetomidine and midazolam for sedation during cesarean delivery in women with pre-eclampsia
Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
PHASE2 · Zagazig University · NCT04873596
This study tests whether using a breathing treatment with dexmedetomidine is better than midazolam for keeping women with pre-eclampsia comfortable during cesarean deliveries.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 21 Years to 38 Years |
| Sex | Female |
| Sponsor | Zagazig University (other gov) |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT04873596 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of nebulized dexmedetomidine compared to nebulized midazolam for procedural sedation during cesarean deliveries in women diagnosed with mild to moderate pre-eclampsia. Conducted as a double-blind randomized trial, participants will be hospitalized a day prior to surgery for a thorough evaluation and informed consent. The study aims to determine if there is a significant difference in sedation efficacy between the two medications when administered under spinal anesthesia. The trial will take place in the operating theater of obstetrics at Zagazig University Hospitals.
Who should consider this trial
Good fit: Ideal candidates are women aged 21-38 with mild to moderate pre-eclampsia who are scheduled for an elective cesarean section under spinal anesthesia.
Not a fit: Patients with severe preeclampsia, altered mental states, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective sedation option for women undergoing cesarean delivery with pre-eclampsia.
How similar studies have performed: While the specific combination of nebulized dexmedetomidine and midazolam is novel, similar studies on sedation techniques in obstetrics have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zagazig
- Zagazig University, Faculty of medicine — Zagazig, Egypt (RECRUITING)
Study contacts
- Principal investigator: Alshaimaa Kamel, M.D — Zagazig University, Faculty of human medicine
- Study coordinator: Alshaimaa Kamel, M.D
- Email: AlshaimaaKamel80@yahoo.com
- Phone: 01005593169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Procedural Sedation