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Dexmedetomidine is a highly selective α₂-adrenergic receptor agonist that exerts its effects by inhibiting the release of norepinephrine at presynaptic nerve terminals, leading to reduced sympathetic activity; This mechanism results in analgesia, sedation, and anxiolysis without significant respiratory depression
In the context of intravenous regional anesthesia (IVRA), dexmedetomidine has been employed as an adjuvant to local anesthetics like lidocaine to improve block characteristics; Clinical studies have demonstrated that adding dexmedetomidine to lidocaine in IVRA accelerates the onset of sensory and motor blocks, extends the duration of postoperative analgesia, and reduces the incidence of tourniquet pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | after spinal anesthesia; patient will receive normal saline injected intravenously below the Pneumatic tourniquet after its inflation |
|
| Dexmedetomidine | Active Comparator | after spinal anesthesia; patient will receive 0.5 mcg/kg dexmedetomidine, diluted in a normal saline injected intravenously below the Pneumatic tourniquet after its inflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | equal volume of normal saline |
| |
| Dexmedetomidine |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative duration of analgesia | the time measured from the study drug injection to the first request of analgesia by the patient | within 24 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| total postoperative analgesic consumption | mg | in the first 24-hour postoperative |
| Sedation levels | Ramsay Sedation Score (RSS) (the score from 1-6; where 1 = anxious, agitated, 2 =cooperatives, oriented, 3 =respond to command only, 4 =brisk response to stimulus, 5 =sluggish response to stimulus, 6 =no response to stimulus) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine-Mansoura University | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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The patient will be allocated into one of two equal (1:1) groups according to the drug injected intravenously below the Pneumatic tourniquet after its inflation. Group D (Dexmedetomidine) will receive 0.5 mcg/kg of dexmedetomidine, diluted in normal saline while, group P (placebo) will receive same volume normal saline
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An anesthetist, not involved in the study , was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drug
| Drug |
0.5 mcg/kg of dexmedetomidine |
|
| done Perioperatively at the following time points (Immediately before spinal anesthesia and immediately before tourniquet deflation. Then 5, 15, 30 min besides, 1, 2, 4, and 6 hours after tourniquet deflation) |
| The time of sensory block regression in both lower limbs | using three-point scale via pinprick test over the limb in both limbs separately (where; 0 = Normal sensation (absent sensory block), 1 = Dull sensation (partial sensory block) and 2 = No sensation (complete sensory block) | Postoperatively every 15 min till full regression of the sensory block (score =0) |
| The motor block regression time in both lower limbs | using Modified Bromage Scale (0-3) | every 15 min till confirmation of full regression of the motor block (Modified Bromage Scale=0) |
| heart rate (HR), | beat per minute | preoperative, immediately after inject both spinal anesthesia and study drug, then every 5 minutes for the first 30 minutes and then every 15 minutes till end of the surgery. also, record after tourniquet deflation 5, 15, 30 min beside 1, 2, 4, 6 hours |
| systolic blood pressure (SBP) | mmHg | preoperative, immediately after inject both spinal anesthesia and study drug, then every 5 minutes for the first 30 minutes and then every 15 minutes till end of the surgery. also, record after tourniquet deflation 5, 15, 30 min beside 1, 2, 4, 6 hours |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |