Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

NCT04394364 | Unknown FDA Device

• 1 other identifier: 2020-02-018AC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bispectral index(BIS) is commonly used to monitor the depth of anesthesia. The electroencephalographic signal is collected and analyzed by the device, resulting a number related to the awareness of the patient. Electromyography is also recorded. The aim of the study is recording and analyzing the data of BIS and try to find it's relation to intraoperative neuromuscular blockade.

Conditions

Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients

Outcome Measures

Primary Outcomes (1)

• Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor

  We will collect EMG activity of bispectral index and train-of-four/count of neuromuscular trasmission monitor in patients undergoing pulmonary surgeries. Total intravenous anesthesia will be given to all included patients, and data will be collected since the induction of anesthesia until extubation of endotracheal tube.By statistical methods, we expect to establish the model predicting intraoperative neuromuscular blockade by EEG activity of BIS monitor.

  six months

Study Arms (1)

BIS monitor group

Patients under monitoring of BIS

Device: Bispectral index

Interventions

Bispectral index DEVICE

The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery

BIS monitor group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing chest surgeries

You may qualify if:

• ASA class between 1 and 3
• Patients scheduled for chest surgery

You may not qualify if:

• Neuromuscular diseases
• Mental and psychiatric disturbance
• ASA class over 4
• Drug abuse
• Aboriginals

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: May 19, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)