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Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.
Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.
Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.
This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine group (B gp) | No Intervention | Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline | |
| Bupivacaine-Dexmedetomidine group (BD gp) | Active Comparator | Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline |
|
| Bupivacaine-Nalbuphine group (BN gp) | Active Comparator | Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The post-operative analgesic duration | during the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory block | from intrathecal injection till sensory block grade 2 at T10 | After intrathecal injection up to 15 minutes |
| Onset of motor block | from intrathecal injection till reach Bromage scale 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University-Emergency hospital-ICU | El Dakahlia | Mansoura | 35511 | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose;
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Intrathecal injectate will be prepared according to the group by an anesthesiologist who is not involved in data collection
| Nalbuphine | Drug | patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline) |
|
| After intrathecal injection up to 15 minutes |
| Heart rate (HR) | beat per minute | Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery |
| Mean arterial pressure (MAP) | mmHg | Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery |
| Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP) | mmHg | every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively |
| Bradycardia will be considered if the heart rate is less than 50 beats/min | beat per minute | every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively |
| postoperative pain | visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable) | at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively |
| side effects as Vomiting, Nausea, pruritus, shivering | incidence | Intraoperatively and for the first 24 hours postoperatively |
| sedation | via Ramsay scale [1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 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 and 6=Patient exhibits no response] | at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |