Anesthetic Component Research on VATS and NIVATS

Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874403
• Other study ID #: 201712125RINB
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anesthesia; Functional
• Thoracoscopy
• Tracheal Intubation

Intervention

Procedure:
• DSA
The changes on DSA on NIVATS and VATS

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of Ce of propofol and remifentanil	The changes of concentration of effective site (Ce) shown on TCI pump before and after intercostal nerve block in NIVATS and VATS groups	four hours in the intraoperative period
Primary	density spectral array changes with thoracoscopic intercostal nerve blocks	a 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).	four hours in the intraoperative period