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This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia
The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.
Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).
Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D3: (dexmedetomidine 3mcg group) | Active Comparator | parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . |
|
| Group D5: (dexmedetomidine 5mcg group) | Active Comparator | parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . |
|
| Group C: (Control group) | Placebo Comparator | parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine 3mcg group | Drug | 3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy on the incidence and severity of shivering associated with spinal anesthesia. | evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia. | Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse effects | the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation. | Immediately after spinal anesthesia, and within 90 minutes later |
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Inclusion Criteria:
Exclusion Criteria:
Full-term pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A. Mahmoud, MD | Contact | 01002538320 | 002 | mohamedali.226@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Osama H. Ahmed, MD | Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Al-Azhar University, Assiut, Egypt | Asyut | 71523 | Egypt |
Data is available with corresponding author on reasonable request
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D044382 | Population Groups |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence.
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Double (Participant, Care Provider)
| dexmedetomidine 5mcg | Drug | 5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline. |
|
| preservative-free 0.9% saline. | Drug | (0.5 ml) preservative-free 0.9% saline |
|
| Mohamed Ali Mahmoud | Asyut | 71523 | Egypt |
|
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |