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The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BF | Active Comparator | Bupivacaine plus Fentanyl |
|
| Group BD | Active Comparator | Bupivacaine plus Dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20% |
|
| Measure | Description | Time Frame |
|---|---|---|
| First time to analgesic requirement | After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time. | First 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid consumption | Total morphine consumption per twenty four hours will be estimated | First 24 hours postoperatively |
| Visual analogue scale (VAS) | Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospitals | Cairo | 11591 | Egypt |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000779 | Anesthetics, Local |
| D005283 | Fentanyl |
| D000701 | Analgesics, Opioid |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Fentanyl | Drug | Plus 50 µg fentanyl |
|
|
| Dexmedetomidine | Drug | Plus 50 µg dexmedetomidine |
|
|
| First 24 hours postoperatively |
| D000588 |
| Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009294 | Narcotics |
| D000700 | Analgesics |
| D007093 | Imidazoles |
| D001393 | Azoles |