Anesthetic Component Research on VATS and NIVATS

NCT03874403 | Completed DMC

• 1 other identifier: 201712125RINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Thoracoscopy; Anesthesia; Functional; Tracheal Intubation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

NIVATS

EXPERIMENTAL

Patients receiving Non-intubated VATS with DSA changes

Procedure: DSA

Intubated VATS

OTHER

Patients receiving intubated VATS with DSA changes

Procedure: DSA

Interventions

DSA PROCEDURE

The changes on DSA on NIVATS and VATS

Intubated VATS; NIVATS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

• ya-jung Cheng

  Department of anesthesiology, National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: compare the DSA monitoring between the patients receiving intubated or NIVATS

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 14, 2019
• Study Start: November 1, 2018
• Primary Completion: October 2, 2019
• Study Completion: September 30, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

TW (1)