Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 3, 2012
April 1, 2012
3 years
May 4, 2012
August 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
incidence of complications
14 days
Other Outcomes (1)
the inflammation level
7 days
Study Arms (2)
no-intubated group
EXPERIMENTALExperimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
intubated group
ACTIVE COMPARATORActive Comparator:double-lumen endotracheal intubated anesthesia
Interventions
VATS under no-intubated thoracic epidural anesthesia
VATS under double-lumen endotracheal intubated anesthesia
Eligibility Criteria
You may qualify if:
- 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）
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510000, China
Related Links
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 4, 2012
First Posted
September 3, 2012
Study Start
July 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2015
Last Updated
September 3, 2012
Record last verified: 2012-04