Clinical trial NCT04873596: Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia
Official title: Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Procedural Sedation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-05-05
Enrollment: 94
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Chane in the level of sedation
timeFrame: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
Secondary outcomes:
measure: The discharge time from Post Anesthesia Care Unite (PACU) .
timeFrame: up to 30 minutes postoperative
measure: Maternal satisfaction with procedure
timeFrame: up to 24hour postoperative
measure: APGAR score
timeFrame: at 1 and 5 min after delivery
measure: Heart rate
timeFrame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
measure: Mean arterial blood pressure
timeFrame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
measure: Oxygen saturation
timeFrame: Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of medicine
Study officials:
affiliation: Zagazig University, Faculty of human medicine
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References: