Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension (POCD-ENT)
26 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
69
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye), 34865
- Kartal Dr. Lutfi Kirdar City Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Desflurane-Remifentanil Group
|
Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
|
Experimentell: Sevoflurane-Remifentanil Group
Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion.
|
Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative cognitive function (POCD)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative cerebral oxygen saturation (rSO2)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2023
Primärt slutförande (Faktisk)
31 juli 2024
Avslutad studie (Faktisk)
31 juli 2024
Studieregistreringsdatum
Först inskickad
21 mars 2026
Först inskickad som uppfyllde QC-kriterierna
26 augusti 2026
Första postat (Faktisk)
28 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 mars 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Postoperativa komplikationer
- Patologiska processer
- Neurokognitiva störningar
- Kognitionsstörningar
- Kognitiv dysfunktion
- Patologiska tillstånd, tecken och symtom
- Postoperativa kognitiva komplikationer
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Eters
- Kolväten
- Kolväten, cykliska
- Syror, acykliska
- Karboxylsyror
- Kolväten, aromatisk
- Piperidiner
- Fenoler
- Bensiverivat
- Kolväten, halogenerad
- Kolväten, fluorerad
- Propionates
- Metyletrar
- Etyletrar
- Remifentanil
- Desfluran
- Sevofluran
- Propofol
Andra studie-ID-nummer
- KDLH-POCD-ENT-2024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .