Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty
25. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
64
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Tyrkiet (Türkiye)
- Gazi University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Nurdan Bedirli, MD, Gazi University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2025
Primær færdiggørelse (Faktiske)
25. februar 2026
Studieafslutning (Faktiske)
25. februar 2026
Datoer for studieregistrering
Først indsendt
20. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. februar 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 172
Plan for individuelle deltagerdata (IPD)
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INGEN
IPD-planbeskrivelse
Individual participant data will not be shared due to institutional and ethical restrictions and to protect participant confidentiality.
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