Nasal SurgeryNCT05654311
Performance of EEG During Emergence Agitation in Nasal Surgery.
An observational study of Nasal Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Nasal Surgery
- What is being tested?
- Nasal surgery
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2023to 26 Oct 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study collects subjects from a tertiary university hospital.
Who may be able to join
- Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent
Who cannot join
- CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
- unable to communicate
- general anesthesia history within 6 months
- disagree to participate in study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital Yonsei University College of Medicine
Seoul
Young Song, 82-2-2019-4601, NEARMYHEART@yuhs.ac
Jiwon Lee, 82-2-2019-4601, BELIEF705@yuhs.ac
About this study
Official title: The Relationship Between Emergence Agitation and Electroencephalogram in Young Adults Undergoing Nasal Surgery Under General Anesthesia
The purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. It is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. Researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.
Read the detailed description
Researchers use Sedline to perform perioperative EEG measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. Emergence agitation occurrence and EEG patterns are observed.
The researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (HADS), postoperative pain, amount of analgesics administered in the surgery/recovery room, and PACU time. Investigators check the correlation between EEG and perioperative variables. Investigators also compare EEG and perioperative variables for those who were given an explanation of emergence agitation and those who were not.
- Conditions
- Nasal Surgery
- Being tested
- Nasal surgery
- Keywords
- general anesthesia, electroencephalogram, emergence agitation, sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal surgeryOther
Nasal surgery under general anesthesia using inhalational agent (sevoflurane)
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG band relative power measured in the frontal lobe
relative power of each brain waves : Original frontal EEG waves using 4 channel sedline (Masimo, Irvine, CA, USA) sensor will processed by FFT(fast Fourier transform). Each band is as follows.: Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz.
Measured: From the cessation of sevoflurane inhalation to the extubation of tracheal tubes
occurrence of emergence agitation
Emergence agitation occurrence : RASS(Richmond Agitation Sedation Score) is 10 scaled (-5~+4) score to assess sedation/agitation level; 0 is a calm state, and a value less than 0 means a sedation state.
Measured: From the cessation of sevoflurane inhalation to transfer to the recovery room
Secondary outcomes (3)
HADS (Hospital Anxiety and Depression Scale)
A self-assessment scale, brief, clinically useful measure of anxiety and depression symptoms. It can be used to diagnose depression in people with significant physical ill-health.
Measured: 1 day before surgery (after admission)
VAS (Visual Analogue Scale)
Using a ruler, it is 11 scaled (0-10) score to assess pain.
Measured: during 30 minutes after PACU admission
Effect of preoperative education on emergence agitation
Investigate the relationship between preoperative emergence agitation explanation and occurrence of emergence agitation
Measured: up to 6 months after completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start2 Jan 2023
- Primary completion26 Oct 2024 (estimated)
- Study completion26 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654311
- Sponsor's protocol ID
- 3-2022-0351
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2022
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Emergence Agitation and Electroencephalogram in Young Adults Undergoing Nasal Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05654311
- Acronym / sponsor ID
- 3-2022-0351
- Conditions
- Nasal Surgery
- Keywords
- general anesthesia, electroencephalogram, emergence agitation, sevoflurane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 26 Oct 2024 (estimated)
- Study completion
- 26 Oct 2024 (estimated)
- First posted
- 16 Dec 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 purpose of the study is to evaluate the relationship between perioperative electroencephalogram and emergence agitation in the nasal surgery. Previous studies showed that low frequency band wave activity increased during emergence delirium in pediatric patients. It is still not enough to explain the relationship between emergence agitation and electroencephalogram in adults. Researchers will demonstrate the relationship between parameters related electroencephalogram and emergence agitation in adults undergoing nasal surgery.
Detailed description
Researchers use Sedline to perform perioperative EEG measurements of young adult patients undergoing nasal surgery under general anesthesia with sevoflurane. Emergence agitation occurrence and EEG patterns are observed.
The researchers record the patient's sex, type of surgery, pre-education on emergence agitation, preoperative hospital anxiety and depression scale (HADS), postoperative pain, amount of analgesics administered in the surgery/recovery room, and PACU time. Investigators check the correlation between EEG and perioperative variables. Investigators also compare EEG and perioperative variables for those who were given an explanation of emergence agitation and those who were not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study collects subjects from a tertiary university hospital.
Key inclusion criteria (1 listed)
- Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent
Key exclusion criteria (4 listed)
- CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
- unable to communicate
- general anesthesia history within 6 months
- disagree to participate in study
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 |
|---|---|---|
| Nasal surgeryNasal surgery under general anesthesia using inhalational agent (sevoflurane) | Other | – |
Primary outcome
EEG band relative power measured in the frontal lobe
Time frame: From the cessation of sevoflurane inhalation to the extubation of tracheal tubes
relative power of each brain waves : Original frontal EEG waves using 4 channel sedline (Masimo, Irvine, CA, USA) sensor will processed by FFT(fast Fourier transform). Each band is as follows.: Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz.
occurrence of emergence agitation
Time frame: From the cessation of sevoflurane inhalation to transfer to the recovery room
Emergence agitation occurrence : RASS(Richmond Agitation Sedation Score) is 10 scaled (-5~+4) score to assess sedation/agitation level; 0 is a calm state, and a value less than 0 means a sedation state.
3 secondary outcomes
HADS (Hospital Anxiety and Depression Scale)
Time frame: 1 day before surgery (after admission)
VAS (Visual Analogue Scale)
Time frame: during 30 minutes after PACU admission
Effect of preoperative education on emergence agitation
Time frame: up to 6 months after completion of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
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 Nasal Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 8 Apr 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 South Korea. 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 Young Song (82-2-2019-6692, NEARMYHEART@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG band relative power measured in the frontal lobe (time frame: From the cessation of sevoflurane inhalation to the extubation of tracheal tubes). The study lists 2 primary outcomes in all. 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 8 Apr 2024.