Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty
25. juni 2026 oppdatert av: Elif KARAKAYA, Gazi University
Observational Evaluation of the Relationship Between Intraoperative Processed EEG Monitoring,Surgical Bleeding and Recovery Quality in Patients Undergoing Rhinoplasty Under Controlled Hypotension
This prospective observational study evaluates intraoperative processed electroencephalography parameters in adult patients undergoing elective rhinoplasty under total intravenous anesthesia with controlled hypotension.
The study focuses on qCON and qNOX values during anesthesia, their relationship with early postoperative recovery, and their association with intraoperative surgical bleeding and surgical field quality.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Controlled hypotension is commonly used during rhinoplasty to improve surgical field visibility and reduce bleeding. However, the adequacy and safety of controlled hypotension should not be evaluated only by hemodynamic variables. Processed EEG monitoring may provide additional information about hypnotic depth and the probability of response to nociceptive stimulation.
In this prospective observational study, adult patients undergoing elective rhinoplasty under general anesthesia were monitored with standard ASA monitoring and processed EEG monitoring. Total intravenous anesthesia was maintained with propofol and remifentanil. Esmolol infusion was used as part of the controlled hypotension strategy. Intraoperative qCON and qNOX values, hemodynamic parameters, surgical bleeding scores, anesthetic drug consumption, extubation time, time to reach Aldrete score ≥9, and early postoperative cognitive recovery were recorded.
The primary objective is to evaluate the intraoperative course of qCON and qNOX values during controlled hypotension. Secondary objectives are to assess the relationship of processed EEG parameters with recovery quality, early postoperative cognitive status, anesthetic drug consumption, and surgical field bleeding.
Studietype
Observasjonsmessig
Registrering (Faktiske)
64
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ankara, Tyrkia (Türkiye)
- Gazi University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adult patients scheduled for elective rhinoplasty under general anesthesia at Gazi University Faculty of Medicine were included in this prospective observational study.
All patients underwent total intravenous anesthesia with esmolol-supported controlled hypotension and intraoperative processed EEG monitoring.
Hemodynamic parameters, qCON and qNOX values, surgical bleeding scores, anesthetic drug consumption, and early postoperative recovery outcomes were recorded.
Beskrivelse
Inclusion Criteria:
- Patients aged 18 years or older
- Patients scheduled for elective rhinoplasty
- Patients classified as ASA physical status I-II
- Patients planned to undergo general anesthesia with total intravenous anesthesia
- Patients in whom frontal processed EEG electrodes can be applied
- Patients who provide written informed consent
Exclusion Criteria:
- Emergency surgery
- Severe neurological disease
- Scalp lesion or marked dermatitis preventing processed EEG electrode placement
- Communication or hearing impairment preventing postoperative assessment
- Marked hemodynamic instability
- Multiple trauma or need for postoperative intensive care unit admission
- Pregnancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intraoperative qCON and qNOX values during controlled hypotension
Tidsramme: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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qCON and qNOX values obtained by processed EEG monitoring will be recorded at predefined intraoperative time points.
qCON will be used as an index of hypnotic depth, and qNOX will be used as an index of the probability of response to nociceptive stimulation.
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From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart rate during controlled hypotension
Tidsramme: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Heart rate will be recorded at predefined intraoperative time points to evaluate hemodynamic stability.
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From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Surgical field bleeding score
Tidsramme: Intraoperatively, from surgical incision until the end of surgery.
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Surgical field bleeding will be evaluated using the Boezaart surgical field bleeding score at predefined intraoperative time points.
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Intraoperatively, from surgical incision until the end of surgery.
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Extubation time
Tidsramme: At the end of surgery
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Time from discontinuation of anesthetic agents to extubation will be recorded in minutes
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At the end of surgery
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Time to reach Aldrete score ≥9
Tidsramme: Early postoperative recovery period, immediately after extubation.
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The time required to reach an Aldrete recovery score of 9 or higher will be recorded in minutes
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Early postoperative recovery period, immediately after extubation.
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Early postoperative delirium assessed by the Nursing Delirium Screening Scale
Tidsramme: At admission to the post-anesthesia care unit
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Patients were assessed for early postoperative delirium in the post-anesthesia care unit using the Nursing Delirium Screening Scale (Nu-DESC).
The Nu-DESC ranges from 0 to 10, with higher scores indicating more severe delirium symptoms.
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At admission to the post-anesthesia care unit
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Total anesthetic drug consumption
Tidsramme: From anesthesia induction until the end of surgery
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Total intraoperative consumption of propofol, remifentanil, and esmolol will be recorded
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From anesthesia induction until the end of surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Nurdan Bedirli, MD, Gazi University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Laferriere-Langlois P, Morisson L, Jeffries S, Duclos C, Espitalier F, Richebe P. Depth of Anesthesia and Nociception Monitoring: Current State and Vision For 2050. Anesth Analg. 2024 Feb 1;138(2):295-307. doi: 10.1213/ANE.0000000000006860. Epub 2024 Jan 12.
- Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.
- Kol IO, Kaygusuz K, Yildirim A, Dogan M, Gursoy S, Yucel E, Mimaroglu C. Controlled hypotension with desflurane combined with esmolol or dexmedetomidine during tympanoplasty in adults: A double-blind, randomized, controlled trial. Curr Ther Res Clin Exp. 2009 Jun;70(3):197-208. doi: 10.1016/j.curtheres.2009.06.001.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2025
Primær fullføring (Faktiske)
25. februar 2026
Studiet fullført (Faktiske)
25. februar 2026
Datoer for studieregistrering
Først innsendt
20. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. februar 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 172
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared due to institutional and ethical restrictions and to protect participant confidentiality.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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