Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
Primary Purpose
Nephrectomy, Lung Diseases, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic Spinal Anesthesia
Thoracic Epidural Anesthesia
Bupivacaine 0.5% (hyperbaric)
Bupivacaine 0.5% (isobaric)
Fentanyl
Dexmedetomidine
Sponsored by

About this trial
This is an interventional supportive care trial for Nephrectomy focused on measuring Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease
Eligibility Criteria
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
Sites / Locations
- Kasr Al-Ainy Hospital, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TSA group
TEA group
Arm Description
Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg & Dexmedetomidine 5 µg by intrathecal injection
Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg & Fentanyl 10-20 µg by epidural injection
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
VAS
Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain].
Mean ABP
Change in Mean Arterial Blood Pressure measured in mmHg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03324490
Brief Title
Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
Official Title
Comparative Study of Mid-thoracic Spinal Versus Epidural Anesthesia for Open Nephrectomy in Patients With Obstructive/Restrictive Lung Disease: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrectomy, Lung Diseases, Anesthesia
Keywords
Mid-thoracic spinal anesthesia, Mid-thoracic epidural anesthesia, Nephrectomy, Lung disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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].
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TSA group
Arm Type
Active Comparator
Arm Description
Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg & Dexmedetomidine 5 µg by intrathecal injection
Arm Title
TEA group
Arm Type
Active Comparator
Arm Description
Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg & Fentanyl 10-20 µg by epidural injection
Intervention Type
Procedure
Intervention Name(s)
Thoracic Spinal Anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Epidural Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% (hyperbaric)
Other Intervention Name(s)
Heavy Marcaine
Intervention Description
Neuro-axially injected
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% (isobaric)
Other Intervention Name(s)
Marcaine
Intervention Description
Neuro-axially injected
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Neuro-axially injected
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Neuro-axially injected
Primary Outcome Measure Information:
Title
Patient Satisfaction Score
Description
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).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
VAS
Description
Visual Analogue Score for pain graded from 0-10 [0: no pain, 10: worst pain].
Time Frame
12 hours
Title
Mean ABP
Description
Change in Mean Arterial Blood Pressure measured in mmHg.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazmy E Seif, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed M El-Badawy, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Al-Ainy Hospital, Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
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