Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
Overview
- Phase
- Phase 2
- Intervention
- Nebulized dexmedetomidine
- Conditions
- Procedural Sedation
- Sponsor
- Zagazig University
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Chane in the level of sedation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Alshaimaa Abdel Fattah Kamel
principle investigator
Zagazig University
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.
Arms & Interventions
nebulized dexmedetomidine
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.
Intervention: Nebulized dexmedetomidine
nebulized midazolam
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.
Intervention: Nebulized midazolam
Outcomes
Primary Outcomes
Chane in the level of sedation
Time Frame: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
Change in the level of sedation will be assessed using Ramasy Sedation Assessment Scale Ramsay Sedation Scale 1= Patient is anxious and agitated or restless, or both 3= Patient responds to commands only 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6= Patient exhibits no response
Secondary Outcomes
- Heart rate(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)
- The discharge time from Post Anesthesia Care Unite (PACU) .(up to 30 minutes postoperative)
- Maternal satisfaction with procedure(up to 24hour postoperative)
- APGAR score(at 1 and 5 min after delivery)
- Mean arterial blood pressure(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)
- Oxygen saturation(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)