Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
NCT ID: NCT03324490
Last Updated: 2019-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-11-01
2018-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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TSA group
Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
Thoracic Spinal Anesthesia
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.
Bupivacaine 0.5% (hyperbaric)
Neuro-axially injected
Fentanyl
Neuro-axially injected
Dexmedetomidine
Neuro-axially injected
TEA group
Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection
Thoracic Epidural Anesthesia
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.
Bupivacaine 0.5% (isobaric)
Neuro-axially injected
Fentanyl
Neuro-axially injected
Interventions
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Thoracic Spinal Anesthesia
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.
Thoracic Epidural Anesthesia
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.
Bupivacaine 0.5% (hyperbaric)
Neuro-axially injected
Bupivacaine 0.5% (isobaric)
Neuro-axially injected
Fentanyl
Neuro-axially injected
Dexmedetomidine
Neuro-axially injected
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild to moderate obstructive or restrictive lung disease
* Open nephrectomy candidate patients
Exclusion Criteria
* Allergic to any of the drugs used during the procedure
18 Years
70 Years
ALL
No
Sponsors
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Nazmy Edward Seif
OTHER
Responsible Party
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Nazmy Edward Seif
Clinical Professor
Principal Investigators
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Nazmy E Seif, MD
Role: STUDY_CHAIR
Kasr Al-Ainy Hospital, Cairo University
Ahmed M El-Badawy, MD
Role: STUDY_DIRECTOR
Kasr Al-Ainy Hospital, Cairo University
Locations
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Kasr Al-Ainy Hospital, Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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TSEANORLDP60
Identifier Type: -
Identifier Source: org_study_id
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