Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension (POCD-ENT)

August 26, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane-Remifentanil Group
Drug: Desflurane
Used for maintenance of anesthesia.
Drug: Remifentanil
Used for maintenance of anesthesia.
Experimental: Sevoflurane-Remifentanil Group
Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion.
Drug: Remifentanil
Used for maintenance of anesthesia.
Drug: Sevoflurane
Used for maintenance of anesthesia.
Experimental: Total Intravenous Anesthesia (Propofol-Remifentanil) Group
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
Drug: Remifentanil
Used for maintenance of anesthesia.
Drug: Propofol (Astra-Zeneca)
Used for maintenance of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative baseline and postoperative day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
15 minutes (T2) and 60 minutes (T5) after intubation.
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.
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
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.
15 minutes (T2) and 60 minutes (T5) after intubation.
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.
15 minutes (T2) and 60 minutes (T5) after intubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

March 21, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDLH-POCD-ENT-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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