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

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.

Study Overview

• Status: Unknown
• Conditions: Anaesthesia; Video Assisted Thoracic Surgery
• Intervention / Treatment: Procedure: no-intubated thoracic epidural anesthesia; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jun Liu, MD.; Phone Number: 13808880646; Email: cuidavil@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recovery time after intervention of each group	the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of complications	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the inflammation level	hemogram and some inflammatory markers	7 days

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: anaesthesia; VATS; nonintubated
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: NTEA001