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

NCT03324490 | Completed DMC

• 1 other identifier: TSEANORLDP60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrectomy; Lung Diseases; Anesthesia

Keywords

Mid-thoracic spinal anesthesia; Mid-thoracic epidural anesthesia; Nephrectomy; Lung disease

Outcome Measures

Primary Outcomes (1)

• 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).

  24 hours

Secondary Outcomes (2)

• VAS

  12 hours

• Mean ABP

  12 hours

Study Arms (2)

TSA group

ACTIVE COMPARATOR

Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection

Procedure: Thoracic Spinal Anesthesia; Drug: Bupivacaine 0.5% (hyperbaric); Drug: Fentanyl; Drug: Dexmedetomidine

TEA group

ACTIVE COMPARATOR

Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection

Procedure: Thoracic Epidural Anesthesia; Drug: Bupivacaine 0.5% (isobaric); Drug: Fentanyl

Interventions

Thoracic Spinal Anesthesia PROCEDURE

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.

TSA group

Thoracic Epidural Anesthesia PROCEDURE

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.

TEA group

Bupivacaine 0.5% (hyperbaric) DRUG

Neuro-axially injected

Also known as: Heavy Marcaine

TSA group

Bupivacaine 0.5% (isobaric) DRUG

Neuro-axially injected

Also known as: Marcaine

TEA group

Fentanyl DRUG

Neuro-axially injected

TEA group; TSA group

Dexmedetomidine DRUG

Neuro-axially injected

TSA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class II or III
• Mild to moderate obstructive or restrictive lung disease
• Open nephrectomy candidate patients

You may not qualify if:

• Any condition contra-indicating regional anesthesia
• Allergic to any of the drugs used during the procedure

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Bupivacaine; Fentanyl; Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Nazmy E Seif, MD

  Kasr Al-Ainy Hospital, Cairo University

  STUDY CHAIR

• Ahmed M El-Badawy, MD

  Kasr Al-Ainy Hospital, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Using computer \& sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia \[TSA group: n=30\] or thoracic epidural anesthesia \[TEA group: n=30\].

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 27, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

EG (1)