Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension (POCD-ENT)
26. august 2026 opdateret af: MELİS ŞEN, Dr. Lutfi Kirdar Kartal Training and Research Hospital
Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia Methods in Terms of Postoperative Cognitive Dysfunction in Ear Surgery Performed Under Controlled Hypotension
This randomized prospective study aimed to compare desflurane, sevoflurane, and total intravenous anesthesia methods in patients undergoing elective ear surgery under controlled hypotension, with a particular focus on postoperative cognitive dysfunction.
In addition to cognitive outcomes, intraoperative hemodynamic parameters, cerebral oxygenation, and perioperative clinical outcomes were evaluated and compared among the three groups.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Controlled hypotension is commonly used in ear surgery to reduce intraoperative bleeding and improve the surgical field. However, the effects of different anesthetic maintenance techniques used during controlled hypotension on postoperative cognitive function remain unclear.
This prospective randomized study included adult patients undergoing elective ear surgery. Patients were randomly assigned to receive desflurane, sevoflurane, or total intravenous anesthesia for maintenance of anesthesia under controlled hypotension.
The primary objective of the study was to evaluate postoperative cognitive dysfunction. Secondary objectives included comparison of intraoperative hemodynamic stability, cerebral oxygenation, and perioperative clinical outcomes among the three anesthesia techniques.
Hemodynamic parameters and cerebral oxygen saturation were recorded at predefined time points during the intraoperative period. Postoperative cognitive function was assessed using standardized cognitive evaluation methods.
The findings of this study aim to contribute to the selection of optimal anesthetic techniques in ear surgery performed under controlled hypotension.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
69
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkiet (Türkiye), 34865
- Kartal Dr. Lutfi Kirdar City Hospital
-
-
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
Beskrivelse
Inclusion Criteria:
- Patients aged 18 years and older
- ASA physical status I-II
- Scheduled for elective tympanoplasty, mastoidectomy, or tympanomastoidectomy under general anesthesia
- Provided written informed consent
Exclusion Criteria:
- Patients with known neurological or psychiatric disorders affecting cognitive function
- Pre-existing cognitive impairment
- Severe hepatic or renal insufficiency
- History of alcohol or substance abuse
- Inability to complete cognitive function tests
- Emergency surgery
- Refusal to participate in the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Desflurane-Remifentanil Group
|
Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
|
Eksperimentel: Sevoflurane-Remifentanil Group
Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion.
|
Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
|
Eksperimentel: Total Intravenous Anesthesia (Propofol-Remifentanil) Group
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
|
Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative cognitive function (POCD)
Tidsramme: Preoperative baseline and postoperative day 7
|
Postoperative cognitive function was evaluated using standardized neurocognitive tests before surgery and on postoperative day 7. Changes from baseline were analyzed to assess postoperative cognitive dysfunction.
|
Preoperative baseline and postoperative day 7
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intraoperative cerebral oxygen saturation (rSO2)
Tidsramme: Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
Regional cerebral oxygen saturation (rSO2) was continuously monitored intraoperatively using near-infrared spectroscopy (NIRS) and compared between groups at predefined time points.
|
Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
|
Mean Arterial Pressure
Tidsramme: Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
Mean arterial pressure (MAP) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
|
Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
|
Arterial Partial Pressure of Oxygen
Tidsramme: 15 minutes (T2) and 60 minutes (T5) after intubation.
|
Arterial partial pressure of oxygen (PaO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
|
15 minutes (T2) and 60 minutes (T5) after intubation.
|
|
Heart Rate
Tidsramme: Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
Heart rate (HR) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
|
Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
|
Arterial Partial Pressure of Carbon Dioxide
Tidsramme: 15 minutes (T2) and 60 minutes (T5) after intubation.
|
Arterial partial pressure of carbon dioxide (PaCO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
|
15 minutes (T2) and 60 minutes (T5) after intubation.
|
|
Blood Lactate Level
Tidsramme: 15 minutes (T2) and 60 minutes (T5) after intubation.
|
Blood lactate level was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
|
15 minutes (T2) and 60 minutes (T5) after intubation.
|
Samarbejdspartnere og efterforskere
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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. december 2023
Primær færdiggørelse (Faktiske)
31. juli 2024
Studieafslutning (Faktiske)
31. juli 2024
Datoer for studieregistrering
Først indsendt
21. marts 2026
Først indsendt, der opfyldte QC-kriterier
26. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Postoperative komplikationer
- Patologiske processer
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Kognitiv dysfunktion
- Patologiske tilstande, tegn og symptomer
- Postoperative kognitive komplikationer
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Ethers
- Kulbrinter
- Kulbrinter, cyklisk
- Syrer, acyklisk
- Carboxylsyrer
- Kulbrinter, aromatisk
- Piperidiner
- Fenoler
- Benzenderivater
- Kulbrinter, halogeneret
- Kulbrinter, fluoreret
- Propionater
- Methylethere
- Ethylethere
- Remifentanil
- Desfluran
- Sevofluran
- Propofol
Andre undersøgelses-id-numre
- KDLH-POCD-ENT-2024
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