Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
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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 |
- 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
- incidence of complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Jun Liu, MD. | 13808880646 | cuidavil@hotmail.com |
| China, Guangdong | |
| the First Affiliated Hospital of Guangzhou Medical College | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Fei Cui, MD.,PhD 08618902301212 4641121@qq.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 |
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 May 19, 2013