Observational of Emergence Time Between Patients Receive General Anesthesia With BIS or Spectrogram EEG Monitor
- Conditions
- General Anesthetic Drug Adverse ReactionPerioperative/Postoperative Complications
- Interventions
- Device: DSA monitor
- Registration Number
- NCT05208502
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- patients who need routine general anesthesia
- have no neurological problem
- have no dermo issue over forehead area
- not allergic to the patch
- patients who is not agreed
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DSA DSA monitor 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 DSA monitor signal. As the surgery ends, this researcher will record the time started from the end of the surgery to extubation, as well as the emergence quality when the patient was evaluated.
- Primary Outcome Measures
Name Time Method DSA monitor group has less emergence time 24 hours Patients with SedLine monitor may have shorter emergence time. The prolonged emergence rate is low with SedLine monitor.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan