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

• Sponsor: Guangzhou Institute of Respiratory Disease (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01677442
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anaesthesia; Video Assisted Thoracic Surgery	Procedure: no-intubated thoracic epidural anesthesia; Procedure: double-lumen endotracheal intubated anesthesia	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2014
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. incidence of complications [14 days]

Other Outcome Measures

1. the inflammation level [7 days]

   hemogram and some inflammatory markers

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Guangzhou Institute of Respiratory Disease

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Jun Liu, Director, Guangzhou Institute of Respiratory Disease
• ClinicalTrials.gov Identifier: NCT01677442
• Other Study ID Numbers: NTEA001
• First Posted: Sep 3, 2012
• Last Update Posted: Sep 3, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Jun Liu, Director, Guangzhou Institute of Respiratory Disease: nonintubated; anaesthesia; VATS
• Additional relevant MeSH terms: Aneurysm, Dissecting; Anesthetics

Study Results

No Results Posted as of Sep 3, 2012