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Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavy Bupivacaine plus normal saline | Active Comparator | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline |
|
| Heavy Bupivacaine plus dexmedetomidine | Experimental | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline |
|
| Heavy Bupivacaine plus midazolam | Experimental | 2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 5 micrograms intrathecal dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sensory block | Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of vomiting occurrence | The patient will be reported in case of vomiting occurrence | 12 hours |
| Sedation | Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Elwasef, MD | NCI Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National cancer institute | Cairo | 11796 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | 2 milligrams intrathecal midazolam |
|
|
| Bupivacain | Drug | 12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine |
|
|
| 12 hours |
| Change in mean arterial blood pressure | Non invasive blood pressure measurement | 12 hours |
| Duration of motor block | Ability of patient to regain full motor power | 12 hours |
| Change in heart rate | Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group | 12 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |