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
  Purpose

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.


Condition Intervention Phase
Anaesthesia
Video Assisted Thoracic Surgery
Procedure: no-intubated thoracic epidural anesthesia
Procedure: double-lumen endotracheal intubated anesthesia
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery

Further study details as provided by Guangzhou Institute of Respiratory Disease:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • incidence of complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • the inflammation level [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    hemogram and some inflammatory markers


Estimated Enrollment: 500
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: no-intubated group
Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
Procedure: no-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
Active Comparator: intubated group
Active Comparator:double-lumen endotracheal intubated anesthesia
Procedure: double-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677442

Contacts
Contact: Jun Liu, MD. 13808880646 cuidavil@hotmail.com

Locations
China, Guangdong
the First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Fei Cui, MD.,PhD    08618902301212    4641121@qq.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Jun Liu, Director, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT01677442     History of Changes
Other Study ID Numbers: NTEA001
Study First Received: May 4, 2012
Last Updated: August 31, 2012
Health Authority: China: Ethics Committee

Keywords provided by Guangzhou Institute of Respiratory Disease:
nonintubated
anaesthesia
VATS

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014