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Anesthetic Component Research on VATS and NIVATS

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National Taiwan University

Status

Completed

Conditions

Tracheal Intubation
Thoracoscopy
Anesthesia; Functional

Treatments

Procedure: DSA

Study type

Interventional

Funder types

Other

Identifiers

NCT03874403
201712125RINB

Details and patient eligibility

About

The non-intubated video-assisted thoracic surgery (NIVATS) can avoid intubation-related complications and for a smoother postoperative recovery. Successful results are accumulating not only from anecdotal case reports of difficult and high-risk patients not suitable for an intubated general anesthesia. However, in spite of safety and feasibility, there were still three main concerns: 1. how to maintain spontaneous breathing with optimal anesthetic depth; 2. How to analyze the components of general anesthesia and regional anesthesia; 3.what's the benefits on the recovery and the risk of aspiration risk with NIVATS? The traditional monitor or methods such as BIS system, SpO2, and follow-up aspiration signs could not offer sufficient evidence to resolve the three main concerns. Recently, there have been many new methods to monitor these concerns. The density spectral array (DSA) BIS system could analyze the change of the anesthetic component. The ORI is a dimensionless index that reflects oxygenation in the moderate hyperoxic range (PaO2 100-200 mmHg).

Full description

Background: The non-intubated video-assisted thoracic surgery (NIVATS) can avoid intubation-related complications and for a smoother postoperative recovery. In recent years, investigator have completed more than 1000 NIVATS. However, the benefits on recovery including swallowing and esophageal function have nerver been demonstrated. The anesthetic components include an intravenous general anesthesia with an intraoperative nerve blocks. Monitoring and analyzing the components of anesthesia have rarely been studied. In this study, the investigator plan to do a radomized control study to demonstarte the differences between NIVATS and intubated VATS, and to investigate the differences on recovery and anesthetic components. Patients schedured for VATS operation, suitable for NIVATS will be included and randomized into NIVATS or VATS groups. DSA and Ce will be monitored throughout the surgical procedures. swalowing test, esophageal function and postoperative qustionare for food intake will be recorded, collected and analyzed.

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients schedured for VATS operations, suitable for NIVATS after anesthetic evaluation

Exclusion criteria

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

NIVATS
Experimental group
Description:
Patients receiving Non-intubated VATS with DSA changes
Treatment:
Procedure: DSA
Intubated VATS
Other group
Description:
Patients receiving intubated VATS with DSA changes
Treatment:
Procedure: DSA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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