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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nebulized dexmedetomidine | Active Comparator | 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. |
|
| nebulized midazolam | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized dexmedetomidine | Drug | parturient will receive nebulized 3ug/kg dexmedetomidine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chane in the level of sedation | 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 | at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| The discharge time from Post Anesthesia Care Unite (PACU) . | 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
SPO2 Maintains SpO2 >92% in ambient air= 2 Maintain SpO2 >90% with O2 = 1 Maintain SpO2 <90% with O2 = 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alshaimaa Kamel, M.D | Contact | 01005593169 | 002 | AlshaimaaKamel80@yahoo.com |
| Dina Abdelhameed Elsadek salem, M.D | Contact | 01099333513 | 002 | dinamagapy@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Alshaimaa Kamel, M.D | Zagazig University, Faculty of human medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University, Faculty of medicine | Recruiting | Zagazig | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nebulized midazolam | Drug | parturient will receive nebulized 0.2 mg/kg midazolam. |
|
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| up to 30 minutes postoperative |
| Maternal satisfaction with procedure | Maternal satisfaction with procedure using a 5-point numerical rating scale. 0= Extremely dissatisfied
| up to 24hour postoperative |
| APGAR score | 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 | at 1 and 5 min after delivery |
| Heart rate | heart rate in beat/ minute | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. |
| Mean arterial blood pressure | Mean arterial blood pressure in mmHg | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. |
| Oxygen saturation | Oxygen saturation by pulse oximetry. | Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative. |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |