Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

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.

Study Overview

• Status: Unknown
• Conditions: Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients
• Intervention / Treatment: Device: Bispectral index

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Department of Anesthesiology, Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing chest surgeries

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIS monitor group; Patients under monitoring of BIS	Device: Bispectral index; The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-02-018AC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be shared to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes