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Anesthetic Component Research on VATS and NIVATS

Advanced Research on the Anesthetic Component and Monitor During the Nonintubated Video-assisted Thoracoscopic Surgery (NIVATS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03874403
Enrollment
60
Registered
2019-03-14
Start date
2018-11-01
Completion date
2020-09-30
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracoscopy, Anesthesia; Functional, Tracheal Intubation

Brief summary

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).

Detailed 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.

Interventions

PROCEDUREDSA

The changes on DSA on NIVATS and VATS

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

compare the DSA monitoring between the patients receiving intubated or NIVATS

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
The changes of Ce of propofol and remifentanilfour hours in the intraoperative periodThe changes of concentration of effective site (Ce) shown on TCI pump before and after intercostal nerve block in NIVATS and VATS groups
density spectral array changes with thoracoscopic intercostal nerve blocksfour hours in the intraoperative perioda colour display that represents the frequencies and amplitudes of brain waves through time, with the colour spectrum ranging from blue (minimum amplitude) to dark red (maximum amplitude).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026