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

Not Applicable

Completed

• Conditions: Nephrectomy; Anesthesia; Lung Diseases
• Interventions: Procedure: Thoracic Spinal Anesthesia; Procedure: Thoracic Epidural Anesthesia; Drug: Bupivacaine 0.5% (hyperbaric); Drug: Bupivacaine 0.5% (isobaric); Drug: Fentanyl; Drug: Dexmedetomidine

• Registration Number: NCT03324490
• Lead Sponsor: Nazmy Edward Seif

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2017-11-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TSA group	Thoracic Spinal Anesthesia	Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
TEA group	Thoracic Epidural Anesthesia	Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection
TSA group	Bupivacaine 0.5% (hyperbaric)	Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
TEA group	Bupivacaine 0.5% (isobaric)	Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection
TSA group	Fentanyl	Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
TSA group	Dexmedetomidine	Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
TEA group	Fentanyl	Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kasr Al-Ainy Hospital, Cairo University; 🇪🇬 Cairo, Egypt