Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery

This study is currently recruiting participants.
Verified April 2012 by Guangzhou Institute of Respiratory Disease
Sponsor:
Information provided by (Responsible Party):
Jun Liu, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT01677442
First received: May 4, 2012
Last updated: August 31, 2012
Last verified: April 2012

May 4, 2012
August 31, 2012
July 2011
July 2014   (final data collection date for primary outcome measure)
recovery time after intervention of each group [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
Same as current
Complete list of historical versions of study NCT01677442 on ClinicalTrials.gov Archive Site
incidence of complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
the inflammation level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
hemogram and some inflammatory markers
Same as current
 
Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery

The purpose of this study is to compare results of general Video-assisted Thoracic Surgery (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.

The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but also a quiet and wide operative field. That's why anaesthesia plays a critical role in thoracoscopic surgery.

General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse effects can derive from this type of anesthesia like intubation-related throat injury, ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid general anesthesia related risks.

Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in such a larger magnitude number and such operation varieties. The investigators hypothesize NTEA could result in less inflammations, lower incidence of complications, less dosage of antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason, the investigators will undertaken a randomized trial comparing results of general VATS operations under NTEA versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.

A total of 500 patients will be included. The study will be performed in the first affiliated hospital of Guangzhou Medical College.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anaesthesia
  • Video Assisted Thoracic Surgery
  • Procedure: no-intubated thoracic epidural anesthesia
    VATS under no-intubated thoracic epidural anesthesia
  • Procedure: double-lumen endotracheal intubated anesthesia
    VATS under double-lumen endotracheal intubated anesthesia
  • Experimental: no-intubated group
    Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
    Intervention: Procedure: no-intubated thoracic epidural anesthesia
  • Active Comparator: intubated group
    Active Comparator:double-lumen endotracheal intubated anesthesia
    Intervention: Procedure: double-lumen endotracheal intubated anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 65 years old
  • signed inform consent
  • Tumor size < 6 cm without right or left bronchus invasion
  • Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L
  • EF > 50%
  • PCO2 < 50mmHg,PO2 > 60mmHg(without uptaking oxygen)

Exclusion Criteria:

  • Psychopath patients who cannot cooperate
  • ASA score greater than 3
  • A history of tuberculosis or other signs of intrapleural adhesions
  • spinal malformation
  • Hypovolemia or coagulation disorders
  • BMI > 30
  • Unfavorable reasons judged by anesthesiologist or surgeon
Both
18 Years to 65 Years
No
Contact: Jun Liu, MD. 13808880646 cuidavil@hotmail.com
China
 
NCT01677442
NTEA001
Yes
Jun Liu, Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease
Not Provided
Study Chair: Jianxing He, Ph.D, M.D. Guangzhou Institute of Respiratory Disease
Study Director: Jun Liu, M.D. Guangzhou Institute of Respiratory Disease
Principal Investigator: Fei Cui, Ph.D, M.D. Guangzhou Institute of Respiratory Disease
Guangzhou Institute of Respiratory Disease
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP