Performance of EEG During Emergence Agitation in Nasal Surgery.

NCT05654311 | Recruiting

• 1 other identifier: 3-2022-0351
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Surgery

Keywords

general anesthesia; electroencephalogram; emergence agitation; sevoflurane

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the cessation of sevoflurane inhalation to transfer to the recovery room

Secondary Outcomes (3)

• HADS (Hospital Anxiety and Depression Scale)

  1 day before surgery (after admission)

• VAS (Visual Analogue Scale)

  during 30 minutes after PACU admission

• Effect of preoperative education on emergence agitation

  up to 6 months after completion of the study

Interventions

Nasal surgery OTHER

Nasal surgery under general anesthesia using inhalational agent (sevoflurane)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study collects subjects from a tertiary university hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Nasal Surgical Procedures

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Young Song

CONTACT

82-2-2019-6692; NEARMYHEART@yuhs.ac

Jiwon Lee

CONTACT

82-2-2019-6807; BELIEF705@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 16, 2022
• Study Start: January 2, 2023
• Primary Completion: October 26, 2024
• Study Completion: October 26, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

KR (1)