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Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSA group | Active Comparator | Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg & Dexmedetomidine 5 µg by intrathecal injection |
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| TEA group | Active Comparator | Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg & Fentanyl 10-20 µg by epidural injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Spinal Anesthesia | Procedure | Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany). When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) & 5 μg dexmedetomidine will be injected. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Score | Patient Satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" & poor "P" (worst score). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain]. | 12 hours |
| Mean ABP | Change in Mean Arterial Blood Pressure measured in mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazmy E Seif, MD | Kasr Al-Ainy Hospital, Cairo University | Study Chair |
| Ahmed M El-Badawy, MD | Kasr Al-Ainy Hospital, Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy Hospital, Cairo University | Cairo | Egypt |
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Using computer & sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia [TSA group: n=30] or thoracic epidural anesthesia [TEA group: n=30].
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|
| Thoracic Epidural Anesthesia | Procedure | Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle & a 20 G epidural catheter. Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose & continued throughout the procedure. |
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| Bupivacaine 0.5% (hyperbaric) | Drug | Neuro-axially injected |
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| Bupivacaine 0.5% (isobaric) | Drug | Neuro-axially injected |
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| Fentanyl | Drug | Neuro-axially injected |
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| Dexmedetomidine | Drug | Neuro-axially injected |
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| 12 hours |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
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