Anesthesia, Lung Diseases, Nephrectomy
Conditions
Keywords
Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease
Brief 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.
Interventions
PROCEDUREThoracic 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.
PROCEDUREThoracic 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.
Neuro-axially injected
DRUGBupivacaine 0.5% (isobaric)
Neuro-axially injected
DRUGFentanyl
Neuro-axially injected
DRUGDexmedetomidine
Neuro-axially injected
Sponsors
Nazmy Edward Seif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Using computer & sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia \[TSA group: n=30\] or thoracic epidural anesthesia \[TEA group: n=30\].
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA class II or III * Mild to moderate obstructive or restrictive lung disease * Open nephrectomy candidate patients
Exclusion criteria
* Any condition contra-indicating regional anesthesia * Allergic to any of the drugs used during the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | 24 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 12 hours | Visual Analogue Score for pain graded from 0-10 \[0: no pain, 10: worst pain\]. |
| Mean ABP | 12 hours | Change in Mean Arterial Blood Pressure measured in mmHg. |
Countries
Egypt
Outcome results
None listed