Postoperative Cognitive Dysfunction (POCD)POCD-ENTNCT07792759
Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension
A study testing Desflurane, Sevoflurane and Remifentanil in people with Postoperative Cognitive Dysfunction (POCD) and Controlled Hypotension for Nasal Surgeries, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction (POCD), Controlled Hypotension for Nasal Surgeries
- What is being tested?
- Desflurane, Sevoflurane and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Istanbul, 34865
About this study
Official title: 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.
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.
- Being tested
- Desflurane, Sevoflurane, Remifentanil, Propofol (Astra-Zeneca)
- Keywords
- Ear Surgery, Desflurane, Total Intravenous Anesthesia, Sevoflurane, Controlled Hypotension, Cognitive Function
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Used for maintenance of anesthesia.
SevofluraneDrug
Used for maintenance of anesthesia.
RemifentanilDrug
Used for maintenance of anesthesia.
Propofol (Astra-Zeneca)Drug
Used for maintenance of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane-Remifentanil Group | Experimental | Desflurane-Remifentanil Group Receives: Drug: Desflurane; Drug: Remifentanil |
| Sevoflurane-Remifentanil Group | Experimental | Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion. Receives: Drug: Sevoflurane; Drug: Remifentanil |
| Total Intravenous Anesthesia (Propofol-Remifentanil) Group | Experimental | Patients received total intravenous anesthesia with propofol and remifentanil infusion. Receives: Drug: Remifentanil; Drug: Propofol (Astra-Zeneca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline and postoperative day 7
Secondary outcomes (6)
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.
Measured: 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
Mean arterial pressure (MAP) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
Measured: 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
Arterial partial pressure of oxygen (PaO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
Measured: 15 minutes (T2) and 60 minutes (T5) after intubation.
Heart Rate
Heart rate (HR) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
Measured: 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
Arterial partial pressure of carbon dioxide (PaCO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
Measured: 15 minutes (T2) and 60 minutes (T5) after intubation.
Blood Lactate Level
Blood lactate level was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
Measured: 15 minutes (T2) and 60 minutes (T5) after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction (POCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MELİS ŞEN, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792759
- Sponsor's protocol ID
- KDLH-POCD-ENT-2024
- Acronym
- POCD-ENT
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia Methods in Terms of Postoperative Cognitive Dysfunction in Ear Surgery Performed Under Controlled Hypotension
- ClinicalTrials.gov ID
- NCT07792759
- Acronym / sponsor ID
- POCD-ENT / KDLH-POCD-ENT-2024
- Keywords
- Ear Surgery, Desflurane, Total Intravenous Anesthesia, Sevoflurane, Controlled Hypotension, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desflurane-Remifentanil Group | Experimental | Drug: Desflurane, Drug: RemifentanilDesflurane-Remifentanil Group |
| Sevoflurane-Remifentanil Group | Experimental | Drug: Sevoflurane, Drug: RemifentanilPatients received general anesthesia with sevoflurane for maintenance and remifentanil infusion. |
| Total Intravenous Anesthesia (Propofol-Remifentanil) Group | Experimental | Drug: Remifentanil, Drug: Propofol (Astra-Zeneca)Patients received total intravenous anesthesia with propofol and remifentanil infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneUsed for maintenance of anesthesia. | Drug | Desflurane-Remifentanil Group |
| SevofluraneUsed for maintenance of anesthesia. | Drug | Sevoflurane-Remifentanil Group |
| RemifentanilUsed for maintenance of anesthesia. | Drug | Desflurane-Remifentanil Group, Sevoflurane-Remifentanil Group, Total Intravenous Anesthesia (Propofol-Remifentanil) Group |
| Propofol (Astra-Zeneca)Used for maintenance of anesthesia. | Drug | Total Intravenous Anesthesia (Propofol-Remifentanil) Group |
Primary outcome
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.
6 secondary outcomes
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).
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).
Arterial Partial Pressure of Oxygen
Time frame: 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).
Arterial Partial Pressure of Carbon Dioxide
Time frame: 15 minutes (T2) and 60 minutes (T5) after intubation.
Blood Lactate Level
Time frame: 15 minutes (T2) and 60 minutes (T5) after intubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane, Sevoflurane and Remifentanil in people with Postoperative Cognitive Dysfunction (POCD) and Controlled Hypotension for Nasal Surgeries, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive function (POCD) (time frame: Preoperative baseline and postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.