Clinical trial
Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
Name
6869
Description
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
Trial arms
Trial start
2021-05-15
Estimated PCD
2024-06-01
Trial end
2024-08-01
Status
Recruiting
Phase
Early phase I
Treatment
Nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine.
Arms:
nebulized dexmedetomidine
Other names:
precedex
Nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam.
Arms:
nebulized midazolam
Other names:
Dormicum
Size
94
Primary endpoint
Chane in the level of sedation
at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 94, 'type': 'ESTIMATED'}}
Updated at
2024-03-01
1 organization
Organization
Zagazig University