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

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01677442
• Other study ID #: NTEA001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 4, 2012
• Last updated: August 31, 2012
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: April 2012
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Jun Liu, MD.
• Phone: 13808880646
• Email: cuidavil[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia
• Video Assisted Thoracic Surgery

Intervention

Procedure:
• no-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
• double-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the inflammation level	hemogram and some inflammatory markers	7 days	Yes
Primary	recovery time after intervention of each group	the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay	7 days	Yes
Secondary	incidence of complications		14 days	Yes

External Links

•   Link