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

Zagazig University

Status and phase: Enrolling; Phase 2

Conditions: Procedural Sedation

Treatments: Drug: Nebulized midazolam; Drug: Nebulized dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04873596

6869 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 21 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

nebulized dexmedetomidine

Active Comparator group

Description:

parturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.

Treatment:

Drug: Nebulized dexmedetomidine

nebulized midazolam

Active Comparator group

Description:

parturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.

Treatment:

Drug: Nebulized midazolam