Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
NCT03324490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-07-23
Summary
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.
Conditions
- Nephrectomy
- Lung Diseases
- Anesthesia
Interventions
- PROCEDURE
-
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.
- PROCEDURE
-
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.
- DRUG
-
Bupivacaine 0.5% (hyperbaric)
Neuro-axially injected
- DRUG
-
Bupivacaine 0.5% (isobaric)
Neuro-axially injected
- DRUG
-
Neuro-axially injected
- DRUG
-
Dexmedetomidine
Neuro-axially injected
Sponsors & Collaborators
-
Nazmy Edward Seif
lead OTHER
Principal Investigators
-
Nazmy E Seif, MD · Kasr Al-Ainy Hospital, Cairo University
-
Ahmed M El-Badawy, MD · Kasr Al-Ainy Hospital, Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2018-06-01
- Completion
- 2018-06-01
Countries
- Egypt
Study Locations
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