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CompletedNCT07792759POCD-ENTUpdated Aug 28, 2026

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

An interventional study of Desflurane and Sevoflurane in Postoperative Cognitive Dysfunction (POCD) and Controlled Hypotension for Nasal Surgeries, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Ear Surgery
  • Desflurane
  • Total Intravenous Anesthesia
  • Sevoflurane
  • Controlled Hypotension
  • Cognitive Function
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Desflurane-Remifentanil Group

    Desflurane-Remifentanil Group

    Drug: Desflurane · Drug: Remifentanil

  • Experimental
    Sevoflurane-Remifentanil Group

    Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion.

    Drug: Sevoflurane · Drug: Remifentanil

  • Experimental
    Total Intravenous Anesthesia (Propofol-Remifentanil) Group

    Patients received total intravenous anesthesia with propofol and remifentanil infusion.

    Drug: Remifentanil · Drug: Propofol (Astra-Zeneca)

Interventions

  • DrugDesflurane

    Used for maintenance of anesthesia.

  • DrugSevoflurane

    Used for maintenance of anesthesia.

  • DrugRemifentanil

    Used for maintenance of anesthesia.

  • DrugPropofol (Astra-Zeneca)

    Used for maintenance of anesthesia.

05

What researchers measure

Primary outcomes

  1. Postoperative cognitive function (POCD)

    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.

    Time frame: Preoperative baseline and postoperative day 7

Secondary outcomes

  1. Intraoperative cerebral oxygen saturation (rSO2)

    Regional cerebral oxygen saturation (rSO2) was continuously monitored intraoperatively using near-infrared spectroscopy (NIRS) and compared between groups at predefined time points.

    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).

  2. Mean Arterial Pressure

    Mean arterial pressure (MAP) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.

    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).

  3. Arterial Partial Pressure of Oxygen

    Arterial partial pressure of oxygen (PaO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.

    Time frame: 15 minutes (T2) and 60 minutes (T5) after intubation.

  4. Heart Rate

    Heart rate (HR) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.

    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).

  5. Arterial Partial Pressure of Carbon Dioxide

    Arterial partial pressure of carbon dioxide (PaCO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.

    Time frame: 15 minutes (T2) and 60 minutes (T5) after intubation.

  6. Blood Lactate Level

    Blood lactate level was measured intraoperatively at predefined time points and compared between the three anesthesia groups.

    Time frame: 15 minutes (T2) and 60 minutes (T5) after intubation.

06

Study locations

1 site
  • Kartal Dr. Lutfi Kirdar City Hospital
    Istanbul, Istanbul 34865, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07792759
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
MELİS ŞEN (Anesthesiology Resident, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Aug 28, 2026
Start date
Dec 1, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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