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Status unknownNCT05654311Updated Apr 8, 2024

Performance of EEG During Emergence Agitation in Nasal Surgery.

An observational study in Nasal Surgery, sponsored by Gangnam Severance Hospital. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Gangnam Severance Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
19 Years to 55 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Nasal Surgery

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Keywords

  • general anesthesia
  • electroencephalogram
  • emergence agitation
  • sevoflurane
03

In context

Emergence Delirium

788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.

This study's planned enrollment of 55 is below the median of 154 across 288 observational studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 145 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study collects subjects from a tertiary university hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 19-55 years who are undergoing nasal surgery under general anesthesia using inhalational agent

Exclusion criteria

Exclusion Criteria:

  • CNS disease (ex.dementia, stroke, brain tumor, psychological disorder..)
  • unable to communicate
  • general anesthesia history within 6 months
  • disagree to participate in study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (estimated)
Patient registry
No

Interventions

  • OtherNasal surgery

    Nasal surgery under general anesthesia using inhalational agent (sevoflurane)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the cessation of sevoflurane inhalation to the extubation of tracheal tubes

  2. 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.

    Time frame: From the cessation of sevoflurane inhalation to transfer to the recovery room

Secondary outcomes

  1. 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.

    Time frame: 1 day before surgery (after admission)

  2. VAS (Visual Analogue Scale)

    Using a ruler, it is 11 scaled (0-10) score to assess pain.

    Time frame: during 30 minutes after PACU admission

  3. Effect of preoperative education on emergence agitation

    Investigate the relationship between preoperative emergence agitation explanation and occurrence of emergence agitation

    Time frame: up to 6 months after completion of the study

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Study locations

1 of 1 sites recruiting
  • Gangnam Severance Hospital Yonsei University College of Medicine
    Seoul, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05654311
Responsible party
Young Song (Associate Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Dec 16, 2022
Start date
Jan 2, 2023
Primary completion
Oct 26, 2024 (estimated)
Completion
Oct 26, 2024 (estimated)
Last update
Apr 8, 2024

Study contacts

Young Song
Contact
NEARMYHEART@yuhs.ac
82-2-2019-6692
Jiwon Lee
Contact
BELIEF705@yuhs.ac
82-2-2019-6807

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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