Postoperative Cognitive Dysfunction (POCD)NCT07701187
Intravenous Anesthesıa and Cognıtıve Functıon ın Spınal Surgery
A study of Postoperative Cognitive Dysfunction (POCD), run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of these two different intravenous infusion techniques [manuel controlled infusion (MCI) and Target controlled Infusion( TCI)] on POCD. To assess POCD, the Mini Mental State Examination (MMSE ) and the Montreal Cognitive Assessment (MoCA ) will be used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction (POCD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2023to 22 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Turkish language proficiency,
- age (18-65 years),
- American Society of Anesthesiologists (ASA) I-III score,
- elective spinal surgery.
Who cannot join
- - refusal to participate
- central nervous system disorders,
- use of antidepressants or antipsychotic medications,
- alcohol or drug use,
- illiteracy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye, BURSA, Bursa 16310, BURSA, Bursa
Bursa, Bursa, 16310
About this study
Official title: The Effect of Two Dıfferent Intravenous Anesthesıa Technıques on Cognıtıve Functıons ın Spınal Surgery
The aim of this study is to investigate the effect of these two different intravenous infusion techniques [manuel controlled infusion (MCI) and Target controlled Infusion( TCI)] on POCD. To assess POCD, the Mini Mental State Examination (MMSE ) and the Montreal Cognitive Assessment (MoCA ) will be used. MoCA and MMSE have high sensitivity and specificity for identifying patients with mild cognitive impairment who perform within the normal range. In a study by Meng et al., comparing target-controlled infusion and manual infusion of propofol anesthesia during electroconvulsive therapy, the randomized, controlled trial showed no significant difference in postelectroconvulsive therapy changes in MoCA scores in either group; however, they reported improvement in MoCA scores after 6 electroconvulsive therapy treatments in the MCI group, while deterioration occurred in the TCI group. Researchers found no studies investigating the effects of both infusion methods in spinal surgery and their impact on cognitive function, and they planned to evaluate the effects of the groups in their study.
- Being tested
- Manual Controlled Infusion (MCI) of Propofol, Target Controlled Infusion (TCI) of Propofol
- Keywords
- target-controlled infusion, Manuel-controlled infüsion, propofol, Post-Operative Cognitive Dysfunction
- 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.
Manual Controlled Infusion (MCI) of PropofolDrug
Propofol infusion initiated at 10 mg/kg/h and decreased to 9 and 6 mg/kg/h at 10-minute intervals, combined with remifentanil (0.5-1 μg/kg/min) titrated to maintain a BIS score of 40-60.
Target Controlled Infusion (TCI) of PropofolDrug
Propofol infused via a TCI device using the Eleveld PK/PD model with an initial target plasma concentration of 2.5-4 μg/mL, combined with remifentanil (0.5-1 μg/kg/min) titrated to maintain a BIS score of 40-60.
| Study group | Role | What they receive |
|---|---|---|
| MCI Group | Active comparator | Manual Controlled Infusion (MCI) group. Anesthesia induced with propofol, rocuronium, and fentanyl. Maintenance achieved with propofol infusion initiated at 10 mg/kg/h and adjusted at 10-minute intervals (9 and 6 mg/kg/h) alongside remifentanil, titrated to maintain a BIS score of 40-60. Receives: Drug: Manual Controlled Infusion (MCI) of Propofol |
| TCI Group | Experimental | Target Controlled Infusion (TCI) group. Anesthesia induced with propofol, rocuronium, and fentanyl. Maintenance achieved with propofol infused via a TCI device using the Eleveld PK/PD model with a target plasma concentration of 2.5-4 μg/mL alongside remifentanil, titrated to maintain a BIS score of 40-60. Receives: Drug: Target Controlled Infusion (TCI) of Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Cognitive Functions Evaluated by the Mini-Mental State Examination
The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function. Postoperative cognitive dysfunction (POCD) is defined as a decrease of at least 1 to 2 points on the MMSE score at the 24th postoperative hour compared to the preoperative baseline values.
Measured: Preoperatively (baseline) and 24 hours postoperatively.
Early Postoperative Cognitive Functions Evaluated by the Montreal Cognitive Assessment
The MoCA is a 30-point screening tool for detecting mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or higher is considered normal. Postoperative cognitive dysfunction (POCD) is defined as a decrease of at least 1 to 2 points on the MoCA score at the 24th postoperative hour compared to the preoperative baseline values.
Measured: Preoperatively (baseline) and 24 hours postoperatively.
Secondary outcomes (8)
Total Intraoperative Propofol Consumption
The total amount of propofol administered throughout the anesthesia duration, measured in milligrams (mg).
Measured: From the initiation of anesthesia induction until the cessation of anesthetic drug infusion at the end of the surgical procedure (assessed at the end of surgery, up to 5 hours).
Total Intraoperative Remifentanil Consumption
The total amount of remifentanil administered throughout the anesthesia duration, measured in micrograms (μg).
Measured: From the initiation of anesthesia induction until the cessation of anesthetic drug infusion at the end of the surgical procedure (assessed at the end of surgery, up to 5 hours).
Intraoperative Heart Rate (HR)
Evaluation of heart rate measured in beats per minute (bpm) to assess intraoperative hemodynamic stability.
Measured: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Intraoperative Mean Arterial Pressure (MAP)
Evaluation of mean arterial pressure measured in millimeters of mercury (mmHg) to assess intraoperative hemodynamic stability.
Measured: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Bispectral Index (BIS) Scores
Continuous monitoring of anesthetic depth using BIS index values (ranging from 0 to 100, where 40-60 indicates adequate general anesthesia).
Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Measured: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Intraoperative Oxygen Saturation (SpO2)
Continuous monitoring of peripheral oxygen saturation percentage (%).
Measured: Intraoperatively from induction until the end of surgery.
Postoperative Recovery Time
The duration (in minutes) from the cessation of anesthetic drug infusion until the patient achieves adequate recovery criteria (Aldrete score ≥ 9 or institutional criteria) for transfer.
Measured: From the time of anesthetic drug cessation (extubation) up to discharge from the operating room / recovery unit (typically assessed up to 60 minutes)
Longitudinal Cognitive Change Scores (Delta)
The calculation of net change scores (Δ) for both MMSE and MoCA, determined by subtracting the preoperative baseline score from the 24-hour postoperative score.
Measured: Calculated at 24 hours postoperatively using baseline data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start22 Sep 2023
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized controlled, single-blind, parallel-group clinical trial designed to compare target-controlled infusion (TCI) and manual-controlled infusion (MCI) of propofol anesthesia in elective spine surgery. Patients are allocated in a 1:1 ratio to receive either MCI (Group 1) or TCI (Group 2) for anesthesia maintenance, with the primary objective of evaluating their respective impacts on early postoperative cognitive functions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, sermın emınoglu, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701187
- Sponsor's protocol ID
- 2011-KAEK-25 2023/09-09
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayburt NS, Duruk Erkent FN, Guven A, Alkis N. Comparison of the Effects of Target-Controlled Versus Conventional Infusion Sedation on Recovery in Geriatric Patients Undergoing Diagnostic Cystoscopy. Turk J Anaesthesiol Reanim. 2026 Feb 9;54(1):40-48. doi: 10.4274/TJAR.2025.252107. Epub 2025 Oct 1.
PubMed 40916451
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Dıfferent Intravenous Anesthesıa Technıques on Cognıtıve Functıons ın Spınal Surgery
- ClinicalTrials.gov ID
- NCT07701187
- Acronym / sponsor ID
- 2011-KAEK-25 2023/09-09
- Keywords
- target-controlled infusion, Manuel-controlled infüsion, propofol, Post-Operative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 14 Jul 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.
The aim of this study is to investigate the effect of these two different intravenous infusion techniques [manuel controlled infusion (MCI) and Target controlled Infusion( TCI)] on POCD. To assess POCD, the Mini Mental State Examination (MMSE ) and the Montreal Cognitive Assessment (MoCA ) will be used. MoCA and MMSE have high sensitivity and specificity for identifying patients with mild cognitive impairment who perform within the normal range. In a study by Meng et al., comparing target-controlled infusion and manual infusion of propofol anesthesia during electroconvulsive therapy, the randomized, controlled trial showed no significant difference in postelectroconvulsive therapy changes in MoCA scores in either group; however, they reported improvement in MoCA scores after 6 electroconvulsive therapy treatments in the MCI group, while deterioration occurred in the TCI group. Researchers found no studies investigating the effects of both infusion methods in spinal surgery and their impact on cognitive function, and they planned to evaluate the effects of the groups in their study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized controlled, single-blind, parallel-group clinical trial designed to compare target-controlled infusion (TCI) and manual-controlled infusion (MCI) of propofol anesthesia in elective spine surgery. Patients are allocated in a 1:1 ratio to receive either MCI (Group 1) or TCI (Group 2) for anesthesia maintenance, with the primary objective of evaluating their respective impacts on early postoperative cognitive functions
| Arm | Type | Receives |
|---|---|---|
| MCI Group | Active comparator | Drug: Manual Controlled Infusion (MCI) of PropofolManual Controlled Infusion (MCI) group. Anesthesia induced with propofol, rocuronium, and fentanyl. Maintenance achieved with propofol infusion initiated at 10 mg/kg/h and adjusted at 10-minute intervals (9 and 6 mg/kg/h) alongside remifentanil, titrated to maintain a BIS score of 40-60. |
| TCI Group | Experimental | Drug: Target Controlled Infusion (TCI) of PropofolTarget Controlled Infusion (TCI) group. Anesthesia induced with propofol, rocuronium, and fentanyl. Maintenance achieved with propofol infused via a TCI device using the Eleveld PK/PD model with a target plasma concentration of 2.5-4 μg/mL alongside remifentanil, titrated to maintain a BIS score of 40-60. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Turkish language proficiency,
- age (18-65 years),
- American Society of Anesthesiologists (ASA) I-III score,
- elective spinal surgery.
Key exclusion criteria (5 listed)
- - refusal to participate
- central nervous system disorders,
- use of antidepressants or antipsychotic medications,
- alcohol or drug use,
- illiteracy.
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 |
|---|---|---|
| Manual Controlled Infusion (MCI) of PropofolPropofol infusion initiated at 10 mg/kg/h and decreased to 9 and 6 mg/kg/h at 10-minute intervals, combined with remifentanil (0.5-1 μg/kg/min) titrated to maintain a BIS score of 40-60. | Drug | MCI Group |
| Target Controlled Infusion (TCI) of PropofolPropofol infused via a TCI device using the Eleveld PK/PD model with an initial target plasma concentration of 2.5-4 μg/mL, combined with remifentanil (0.5-1 μg/kg/min) titrated to maintain a BIS score of 40-60. | Drug | TCI Group |
Primary outcome
Early Postoperative Cognitive Functions Evaluated by the Mini-Mental State Examination
Time frame: Preoperatively (baseline) and 24 hours postoperatively.
The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function. Postoperative cognitive dysfunction (POCD) is defined as a decrease of at least 1 to 2 points on the MMSE score at the 24th postoperative hour compared to the preoperative baseline values.
Early Postoperative Cognitive Functions Evaluated by the Montreal Cognitive Assessment
Time frame: Preoperatively (baseline) and 24 hours postoperatively.
The MoCA is a 30-point screening tool for detecting mild cognitive impairment. Scores range from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or higher is considered normal. Postoperative cognitive dysfunction (POCD) is defined as a decrease of at least 1 to 2 points on the MoCA score at the 24th postoperative hour compared to the preoperative baseline values.
8 secondary outcomes
Total Intraoperative Propofol Consumption
Time frame: From the initiation of anesthesia induction until the cessation of anesthetic drug infusion at the end of the surgical procedure (assessed at the end of surgery, up to 5 hours).
Total Intraoperative Remifentanil Consumption
Time frame: From the initiation of anesthesia induction until the cessation of anesthetic drug infusion at the end of the surgical procedure (assessed at the end of surgery, up to 5 hours).
Intraoperative Heart Rate (HR)
Time frame: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Intraoperative Mean Arterial Pressure (MAP)
Time frame: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Bispectral Index (BIS) Scores
Time frame: Intraoperatively at 5, 10, and 15 minutes after induction, and every 30 minutes thereafter until the end of surgery.
Intraoperative Oxygen Saturation (SpO2)
Time frame: Intraoperatively from induction until the end of surgery.
Postoperative Recovery Time
Time frame: From the time of anesthetic drug cessation (extubation) up to discharge from the operating room / recovery unit (typically assessed up to 60 minutes)
Longitudinal Cognitive Change Scores (Delta)
Time frame: Calculated at 24 hours postoperatively using baseline data.
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 2 Nov 2026.
- Background: PubMed 40916451Bayburt NS, Duruk Erkent FN, Guven A, Alkis N. Comparison of the Effects of Target-Controlled Versus Conventional Infusion Sedation on Recovery in Geriatric Patients Undergoing Diagnostic Cystoscopy. Turk J Anaesthesiol Reanim. 2026 Feb 9;54(1):40-48. doi: 10.4274/TJAR.2025.252107. Epub 2025 Oct 1.
- Individual participant dataSharing planned: No
Related trials for Postoperative Cognitive Dysfunction (POCD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
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 of Postoperative Cognitive Dysfunction (POCD), run by Bursa Yuksek Ihtisas 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 5 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 2 Nov 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?
Early Postoperative Cognitive Functions Evaluated by the Mini-Mental State Examination (time frame: Preoperatively (baseline) and 24 hours postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07701187, which also lists 1 linked publication.
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 2 Nov 2026.