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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208502
Other study ID # 201912250RINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2022
Est. completion date December 31, 2024

Study information

Verified date February 2023
Source National Taiwan University Hospital
Contact Feng-Fang Tsai
Phone 886-2-3123456
Email 010388@ntuh.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The bispectral index parameter is used to guide the titration of general anesthesia, however; conflicting results between different studies cannot prove the benefit of EEG monitor on improvement of OR efficiency. Next Generation SedLine features an enhanced signal processing engine, which provides processed EEG parameters. This four channel EEG monitor for the monitoring of perioperative anesthesia depth prevent overdose of medication and may help for individualized anesthetic plan. This research intended to observe the emergence time from end of the surgical wound closure to patient awake (or to extubation) with or without SedLine.


Description:

This is a clinical observation study. Inclusion criteria are patients with ASA 1-3, age over 20 who need general anesthesia surgery without other neurologic disease. All inclusions will receive the general anesthesia with SedLine monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG monitor signal. The Controls were patients with same criteria without BIS monitor. Sample size was decided if the estimated difference between SedLine group and BIS group are 1 minute and the average estimated as 2 minute. With 80% desired power and default is .05, each group will need 63 cases.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - patients who need routine general anesthesia - have no neurological problem - have no dermo issue over forehead area - not allergic to the patch Exclusion Criteria: - patients who is not agreed

Study Design


Related Conditions & MeSH terms

  • Drug-Related Side Effects and Adverse Reactions
  • General Anesthetic Drug Adverse Reaction
  • Perioperative/Postoperative Complications
  • Postoperative Complications

Intervention

Device:
DSA monitor
Next Generation SedLine features an enhanced signal processing engine, which provides processed EEG parameters. This four channel EEG monitor for the monitoring of perioperative anesthesia depth prevent overdose of medication and may help for individualized anesthetic plan

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 DSA monitor group has less emergence time Patients with SedLine monitor may have shorter emergence time. The prolonged emergence rate is low with SedLine monitor. 24 hours
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