NCT03324490

Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients

Comparative Study of Mid-thoracic Spinal Versus Epidural Anesthesia for Open Nephrectomy in Patients With Obstructive/Restrictive Lung Disease: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Nazmy Edward Seif · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Fentanyl	Neuro-axially injected
DRUG	Dexmedetomidine	Neuro-axially injected

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2017-10-27
• Last updated: 2019-07-23

Locations

1 site across 1 country: Egypt