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

Phase 1

• Conditions: Anaesthesia; Video Assisted Thoracic Surgery
• Interventions: Procedure: no-intubated thoracic epidural anesthesia; Procedure: double-lumen endotracheal intubated anesthesia

• Registration Number: NCT01677442
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2012-04
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-08-31
• Last Update Submitted: 2012-08-31
• Study First Posted: 2012-09-03
• Last Update Posted: 2012-09-03
• Primary Completion: 2014-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no-intubated group	no-intubated thoracic epidural anesthesia	Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
intubated group	double-lumen endotracheal intubated anesthesia	Active Comparator:double-lumen endotracheal intubated anesthesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
incidence of complications	14 days

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China