Procedural Sedation
Conditions
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.
Interventions
parturient will receive nebulized 3ug/kg dexmedetomidine.
parturient will receive nebulized 0.2 mg/kg midazolam.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 38 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chane in the level of sedation | 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
| Measure | Time frame | Description |
|---|---|---|
| Maternal satisfaction with procedure | up to 24hour postoperative | Maternal satisfaction with procedure using a 5-point numerical rating scale. 0= Extremely dissatisfied 1. Dissatisfied 2. Neutral 3. Satisfied 4. Extremely satisfied |
| APGAR score | at 1 and 5 min after delivery | APGAR score at 1 and 5 min after delivery APGAR score (13). Indicator Score 0 Score 1 Score 2 Activity (muscle tone) Limp; no movement Some flexion of arms and legs Active motion Pulse (heart rate) No heart rate Fewer than 100 beats per minute At least 100 beats per minute Grimace (reflex response) No response to airways being suctioned Grimace during suctioning Grimace and pull away, cough, or sneeze during suctioning Appearance (color) The baby's whole body is completely bluish-gray or pale Good color in body with bluish hands or feet Good color all over Respiration (breathing) Not breathing Weak cry; may sound like whimpering, slow or irregular breathing Good, strong cry; normal rate and effort of breathing Total Score: 3 and below require immediate resuscitation 4 to 7 may require resuscitative measures 7 to 10 is considered normal |
| The discharge time from Post Anesthesia Care Unite (PACU) . | up to 30 minutes postoperative | The discharge time from Post Anesthesia Care Unite (PACU) in minutes when achieving modified Aldrete Score 9. Modified Aldert Score. Activity, able to move, voluntarily or on command 4 extremities = 2 2 extremities = 1 No = 0 Breathing Able to breathe deeply & cough freely= 2 Dyspnea, shallow or limited breathing =1 Apnea= 0 Consciousness Fully awake = 2 Arousable on calling = 1 Unresponsive = 0 Circulation (BP) ±20% of pre-anesthesia level= 2 * 20% to 49% of pre-anesthesia level= 1 * 50% of pre-anesthesia level= 0 SPO2 Maintains SpO2 \>92% in ambient air= 2 Maintain SpO2 \>90% with O2 = 1 Maintain SpO2 \<90% with O2 = 0 |
| Mean arterial blood pressure | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. | Mean arterial blood pressure in mmHg |
| Oxygen saturation | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. | Oxygen saturation by pulse oximetry. |
| Heart rate | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. | heart rate in beat/ minute |
Countries
Egypt
Contacts
Primary ContactAlshaimaa Kamel, M.D
Backup ContactDina Abdelhameed Elsadek salem, M.D
Outcome results
None listed