Clinical Trials Directory

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UnknownNCT01677442

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

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
500 (estimated)
Sponsor
Guangzhou Institute of Respiratory Disease · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREno-intubated thoracic epidural anesthesiaVATS under no-intubated thoracic epidural anesthesia
PROCEDUREdouble-lumen endotracheal intubated anesthesiaVATS under double-lumen endotracheal intubated anesthesia

Timeline

Start date
2011-07-01
Primary completion
2014-07-01
Completion
2015-07-01
First posted
2012-09-03
Last updated
2012-09-03

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01677442. Inclusion in this directory is not an endorsement.