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The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia.
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block, and postoperative analgesia. All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anesthesia and maintenance volume of 10ml\kg.
For each group, patients will be put in sitting position, lumbar puncture will be performed under complete aseptic precautions, local anesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • control | Active Comparator | • Drug: hyperbaric bupivacaine this group will be given 3 ml (15mg) of 0.5% hyperbaric bupivacaine+0.5 ml of normal saline intrathecally. |
|
| •Fentanyl group | Active Comparator | •Drug: Fentanyl this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (25μg) of fentanyl intrathecally. |
|
| •Dexmedetomidine group | Active Comparator | •this group will be given 3 ml (15 mg) of 0.5% hyperbaric bupivacaine+0.5 ml (5μg) of diluted dexmedetomidine intrathecally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | patient will be given 3ml (15mg) of 0.5% hyperbaric bupivacaine + 0.5 ml of normal saline intrathecally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| motor blockade onset | Onset of motor block (defined as time in minutes from the end of drug injection intrathecally until patient is unable to move the hip, knee, and ankle) | from injection up to Modified Bromage score 1 ( 5 minutes) |
| sesnory onset | defined as time in minutes to reach highest sensory level) will be tested every minute after intrathecal injection until it reach the highest level. It will be assessed by pin prick and cold application | from injection up to s1 regression ( 5 minutes) |
| post operative analgesia | will be evaluated using a visual analog scale (VAS), | from injection up to 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| drop in mean blood pressure | using non invasive arterial blood pressure monitoring | from injection up to 24 hours post operative |
| drop in oxygen saturation | using pulse oximiter |
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Inclusion Criteria:
• ASA I or ASA II patients Scheduled for pott's, of either sex.
Exclusion Criteria:
• Patients with known neurologic and psychiatric illness.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Abbassia | 00202 | 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 |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Fentanyl | Drug | patients will be given 3ml (15mg) of 0.5%hyperbaric bupivacaine +0.5ml (25 microgram) of fentanyl intrathecally |
|
| Dexmedetomidine | Drug | patient will receive 3ml (15mg) of .05 hyperbaric bupivacaine 0.5ml(5 microgram) of diluted dexmedetomidine intrathecally |
|
|
| from injection up to24hours post operative |
| drop in heart rate | using ecg monitoring | from injection up to 24 hours post operative |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |