Clinical trial NCT01677442: Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
Official title: Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Anaesthesia
Video Assisted Thoracic Surgery
Keywords: nonintubated
anaesthesia
VATS
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: recovery time after intervention of each group
timeFrame: 7 days
Secondary outcomes:
measure: incidence of complications
timeFrame: 14 days
Other outcomes:
measure: the inflammation level
timeFrame: 7 days
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Jianxing He, Ph.D, M.D.
role: STUDY_CHAIR
affiliation: Guangzhou Institute of Respiratory Disease
name: Jun Liu, M.D.
role: STUDY_DIRECTOR
affiliation: Guangzhou Institute of Respiratory Disease
name: Fei Cui, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References: