Anaesthesia, Video Assisted Thoracic Surgery
Conditions
Keywords
nonintubated, anaesthesia, VATS
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.
Interventions
PROCEDUREno-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
PROCEDUREdouble-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recovery time after intervention of each group | 7 days | the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay |
Secondary
| Measure | Time frame |
|---|---|
| incidence of complications | 14 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| the inflammation level | 7 days | hemogram and some inflammatory markers |
Countries
China
Contacts
Primary ContactJun Liu, MD.
Outcome results
None listed