Performance of EEG During Emergence Agitation in Nasal Surgery.

Recruiting

• Conditions: Nasal Surgery

• Registration Number: NCT05654311
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Study Start: 2023-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-10-26
• Study Completion: 2024-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EEG band relative power measured in the frontal lobe	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	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.

Secondary Outcome Measures

Name	Time	Method
HADS (Hospital Anxiety and Depression Scale)	1 day before surgery (after admission)	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.
Effect of preoperative education on emergence agitation	up to 6 months after completion of the study	Investigate the relationship between preoperative emergence agitation explanation and occurrence of emergence agitation
VAS (Visual Analogue Scale)	during 30 minutes after PACU admission	Using a ruler, it is 11 scaled (0-10) score to assess pain.

Trial Locations

Locations (1)

Gangnam Severance Hospital Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of