Clinical trial NCT03874403: Anesthetic Component Research on VATS and NIVATS
Official title: Advanced Research on the Anesthetic Component and Monitor During the Nonintubated Video-assisted Thoracoscopic Surgery (NIVATS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracoscopy
Anesthesia; Functional
Tracheal Intubation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compare the DSA monitoring between the patients receiving intubated or NIVATS
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: The changes of Ce of propofol and remifentanil
timeFrame: four hours in the intraoperative period
measure: density spectral array changes with thoracoscopic intercostal nerve blocks
timeFrame: four hours in the intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of anesthesiology, National Taiwan University Hospital
name: ya-jung Cheng
role: STUDY_DIRECTOR
References: