Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients Clinical Trial

Official title:

Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04394364
• Other study ID #: 2020-02-018AC
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients

Intervention

Device:
• Bispectral index
The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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