Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
|ClinicalTrials.gov Identifier: NCT01677442|
Recruitment Status : Unknown
Verified April 2012 by Jun Liu, Guangzhou Institute of Respiratory Disease.
Recruitment status was: Recruiting
First Posted : September 3, 2012
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anaesthesia Video Assisted Thoracic Surgery||Procedure: no-intubated thoracic epidural anesthesia Procedure: double-lumen endotracheal intubated anesthesia||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2015|
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
- recovery time after intervention of each group [ Time Frame: 7 days ]the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
- incidence of complications [ Time Frame: 14 days ]
- the inflammation level [ Time Frame: 7 days ]hemogram and some inflammatory markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677442
|Contact: Jun Liu, MD.||firstname.lastname@example.org|
|the First Affiliated Hospital of Guangzhou Medical College||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Fei Cui, MD.,PhD 08618902301212 email@example.com|
|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|