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

NCT03324490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nazmy Edward Seif

    lead OTHER

Principal Investigators

  • Nazmy E Seif, MD · Kasr Al-Ainy Hospital, Cairo University

  • Ahmed M El-Badawy, MD · Kasr Al-Ainy Hospital, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324490 on ClinicalTrials.gov