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Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension

Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia Methods in Terms of Postoperative Cognitive Dysfunction in Ear Surgery Performed Under Controlled Hypotension

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07792759
Acronym
POCD-ENT
Enrollment
69
Registered
2026-08-28
Start date
2023-12-01
Completion date
2024-07-31
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controlled Hypotension for Nasal Surgeries, Postoperative Cognitive Dysfunction (POCD)

Keywords

Ear Surgery, Desflurane, Total Intravenous Anesthesia, Sevoflurane, Controlled Hypotension, Cognitive Function

Brief summary

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.

Detailed description

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.

Interventions

DRUGDesflurane

Used for maintenance of anesthesia.

DRUGSevoflurane

Used for maintenance of anesthesia.

DRUGRemifentanil

Used for maintenance of anesthesia.

Used for maintenance of anesthesia.

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessments were performed by an independent investigator who was blinded to group allocation. The individual responsible for intraoperative management and intervention was different from the investigator performing postoperative evaluations.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative cognitive function (POCD)Preoperative baseline and postoperative day 7Postoperative 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.

Secondary

MeasureTime frameDescription
Intraoperative cerebral oxygen saturation (rSO2)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.
Mean Arterial PressurePreoperative 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.
Arterial Partial Pressure of Oxygen15 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.
Heart RatePreoperative 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.
Arterial Partial Pressure of Carbon Dioxide15 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.
Blood Lactate Level15 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026