General Anesthetic Drug Adverse ReactionNCT05208502
Observational of Emergence Time Between Patients Receive General Anesthesia With BIS or Spectrogram EEG Monitor
An observational study of General Anesthetic Drug Adverse Reaction and Perioperative/Postoperative Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction, Perioperative/Postoperative Complications
- What is being tested?
- DSA monitor
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who need routine general anesthesia
Who may be able to join
- patients who need routine general anesthesia
- have no neurological problem
- have no dermo issue over forehead area
- not allergic to the patch
Who cannot join
- patients who is not agreed
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Feng-Fang Tsai, 0972653390, 010388@ntuh.gov.tw
About this study
Official title: Observation of Emergence Time Between Patients Receive General Anesthesia With BIS or 4-channel Spectrogram EEG Monitor
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.
Read the 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.
- Being tested
- DSA monitor
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA monitorDevice
Also called the time when the inclusion started emergence to extubation will be recorded
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
| Study group | Role | What they receive |
|---|---|---|
| BIS | All inclusions will receive the general anesthesia with BIS monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG 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. | |
| DSA | 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. Receives: Device: DSA monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start22 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Fang Tsai, MD, PhD, Principal investigator, Operation Theater, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208502
- Sponsor's protocol ID
- 201912250RINC
- Status last verified
- Feb 2023
- First submitted
- 4 Jun 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Emergence Time Between Patients Receive General Anesthesia With BIS or 4-channel Spectrogram EEG Monitor
- ClinicalTrials.gov ID
- NCT05208502
- Acronym / sponsor ID
- 201912250RINC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS | – | –All inclusions will receive the general anesthesia with BIS monitor, a researcher who is not participated in the clinical practice will record the emergence characters and the EEG 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. |
| DSA | – | Device: DSA monitorAll 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who need routine general anesthesia
Key inclusion criteria (4 listed)
- patients who need routine general anesthesia
- have no neurological problem
- have no dermo issue over forehead area
- not allergic to the patch
Key exclusion criteria (1 listed)
- patients who is not agreed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSA monitorAlso: the time when the inclusion started emergence to extubation will be recordedNext 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 | Device | DSA |
Primary outcome
DSA monitor group has less emergence time
Time frame: 24 hours
Patients with SedLine monitor may have shorter emergence time. The prolonged emergence rate is low with SedLine monitor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Fang Tsai, MD, PhD principal investigator
Operation Theater, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetic Drug Adverse Reaction and Perioperative/Postoperative Complications, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng-Fang Tsai (886-2-3123456 ext. 62158, 010388@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSA monitor group has less emergence time (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.