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NCT Number: NCT07792759

Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

Used for maintenance of anesthesia.

Sevoflurane

Drug

Used for maintenance of anesthesia.

Remifentanil

Drug

Used for maintenance of anesthesia.

Propofol (Astra-Zeneca)

Drug

Used for maintenance of anesthesia.

Primary outcomes

  1. Postoperative cognitive function (POCD)

    Time frame: 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.

Secondary outcomes

  1. Intraoperative cerebral oxygen saturation (rSO2)

    Time frame: 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.

  2. Mean Arterial Pressure

    Time frame: 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.

  3. Arterial Partial Pressure of Oxygen

    Time frame: 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.

  4. Heart Rate

    Time frame: 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.

  5. Arterial Partial Pressure of Carbon Dioxide

    Time frame: 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.

  6. Blood Lactate Level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: POCD-ENT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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