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

NCT07792759 | Completed

• 1 other identifier: KDLH-POCD-ENT-2024
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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.

  Preoperative baseline and postoperative day 7

Secondary Outcomes (6)

• 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).

• Mean Arterial Pressure

  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

  15 minutes (T2) and 60 minutes (T5) after intubation.

• Heart Rate

  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

  15 minutes (T2) and 60 minutes (T5) after intubation.

Study Arms (3)

Desflurane-Remifentanil Group

EXPERIMENTAL

Desflurane-Remifentanil Group

Drug: Desflurane; Drug: Remifentanil

Sevoflurane-Remifentanil Group

EXPERIMENTAL

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

Drug: Sevoflurane; Drug: Remifentanil

Total Intravenous Anesthesia (Propofol-Remifentanil) Group

EXPERIMENTAL

Patients received total intravenous anesthesia with propofol and remifentanil infusion.

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

Interventions

Desflurane DRUG

Used for maintenance of anesthesia.

Desflurane-Remifentanil Group

Sevoflurane DRUG

Used for maintenance of anesthesia.

Sevoflurane-Remifentanil Group

Remifentanil DRUG

Used for maintenance of anesthesia.

Desflurane-Remifentanil Group; Sevoflurane-Remifentanil Group; Total Intravenous Anesthesia (Propofol-Remifentanil) Group

Propofol (Astra-Zeneca) DRUG

Used for maintenance of anesthesia.

Total Intravenous Anesthesia (Propofol-Remifentanil) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Desflurane; Sevoflurane; Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: August 28, 2026
• Study Start: December 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)