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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Anaesthesia, Video Assisted Thoracic Surgery

Intervention / Treatment
-----------------
* Procedure: no-intubated thoracic epidural anesthesia
* Procedure: double-lumen endotracheal intubated anesthesia


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no-intubated group<br>Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace | Procedure: no-intubated thoracic epidural anesthesia<br>* VATS under no-intubated thoracic epidural anesthesia<br>|
| Active Comparator: intubated group<br>Active Comparator:double-lumen endotracheal intubated anesthesia | Procedure: double-lumen endotracheal intubated anesthesia<br>* VATS under double-lumen endotracheal intubated anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time after intervention of each group | the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonintubated, anaesthesia, VATS