Condition / Focus: Postoperative Cognitive Dysfunction (POCD) Following Spinal SurgerySEVO-PROP-MMSENCT07378878
COMPARISON OF SEVOFLURANE AND PROPOFOL ADMINISTRATION ON POSTOPERATIVE COGNITIVE DYSFUNCTION IN SPINAL SURGERY USING THE MINI-MENTAL STATE EXAMINATION (MMSE)
A study testing Sevoflurane Administration and Propofol Administration in people with Condition / Focus: Postoperative Cognitive Dysfunction (POCD) Following Spinal Surgery, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
This study aims to compare the effects of two commonly used anesthetic agents, sevoflurane and propofol, on cognitive function after spinal surgery. Postoperative cognitive dysfunction (POCD) is a common complication following general anesthesia, particularly in complex procedures such as spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Condition / Focus: Postoperative Cognitive Dysfunction (POCD) Following Spinal Surgery
- What is being tested?
- Sevoflurane Administration and Propofol Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2025to 15 May 2025
- 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
- Patients scheduled for elective spinal surgery.
- Age between 18 and 65 years.
- ASA (American Society of Anesthesiologists) physical status I-II.
- Able to give informed consent.
- Willing to participate in all cognitive assessments (MMSE) before and after surgery.
Who cannot join
- History of neurological disorders (e.g., dementia, stroke, epilepsy).
- Severe psychiatric disorders.
- Known allergy or contraindication to sevoflurane or propofol.
- History of drug or alcohol abuse.
- Patients undergoing emergency spinal surgery.
- Inability to understand or complete MMSE assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sevoflurane and Propofol Administration on Postoperative Cognitive Dysfunction in Spinal Surgery Using the Mini-Mental State Examination (MMSE)
This study aims to compare the effects of two commonly used anesthetic agents, sevoflurane and propofol, on cognitive function after spinal surgery. Postoperative cognitive dysfunction (POCD) is a common complication following general anesthesia, particularly in complex procedures such as spinal surgery. The Mini-Mental State Examination (MMSE) will be used to assess cognitive function before surgery and at multiple time points after surgery (6 hours, 24 hours, 3 days, and 7 days).
Twenty patients undergoing elective spinal surgery will be randomly assigned to receive either sevoflurane or propofol anesthesia. Cognitive outcomes will be measured and compared between the two groups. The study will evaluate whether propofol offers better preservation of cognitive function compared to sevoflurane, which has been associated with oxidative stress and hippocampal dysfunction.
The results of this study will provide important information for anesthesiologists and surgical teams regarding the choice of anesthetic agents to minimize cognitive decline after spinal surgery, improving patient safety and postoperative recovery.
Read the detailed description
Background:
Postoperative cognitive dysfunction (POCD) is a recognized complication following general anesthesia, particularly in major surgeries such as spinal procedures. POCD can affect memory, attention, and other cognitive domains, impacting patient recovery, quality of life, and independence after surgery. Sevoflurane, an inhalational anesthetic, has been associated with neurotoxic effects including oxidative stress and hippocampal dysfunction, which may contribute to POCD. Propofol, an intravenous anesthetic, exhibits antioxidative and anti-inflammatory properties, potentially offering neuroprotective effects.
Objective:
The primary objective of this study is to compare the incidence and severity of POCD in patients undergoing spinal surgery under sevoflurane versus propofol anesthesia, as assessed by the Mini-Mental State Examination (MMSE).
Methods:
This is a single-blind, randomized controlled trial involving 20 adult patients scheduled for elective spinal surgery at Universitas Sumatera Utara / RSUP H. Adam Malik Medan. Patients will be randomly allocated into two groups (n=10 per group) to receive either sevoflurane or propofol for general anesthesia.
Cognitive Assessment:
MMSE will be administered at the following time points:
Preoperatively (baseline)
6 hours postoperatively
24 hours postoperatively
3 days postoperatively
7 days postoperatively
Outcomes:
Primary Outcome: MMSE score change from baseline at each postoperative time point.
Secondary Outcomes: Incidence of mild or moderate POCD, defined according to MMSE decline; comparison of cognitive recovery trends between groups.
Statistical Analysis:
Descriptive statistics for demographic data.
Independent t-tests and chi-square tests to compare cognitive outcomes between groups.
Pearson correlation for analyzing associations between variables.
Significance threshold: p < 0.05.
Expected Results:
It is hypothesized that patients receiving propofol will demonstrate more stable MMSE scores postoperatively, whereas patients receiving sevoflurane may experience significant cognitive decline, particularly at 3 and 7 days after surgery.
Significance:
The study will provide evidence-based guidance for anesthetic selection in spinal surgery to minimize the risk of postoperative cognitive decline. This may improve patient recovery, satisfaction, and overall outcomes in surgical care.
Ethical Considerations:
The study has been approved by the Universitas Sumatera Utara Ethical Review Board (No. 88/KEPK/USU/2025). Informed consent will be obtained from all participants prior to enrollment.
- Being tested
- Sevoflurane Administration, Propofol Administration
- Keywords
- Postoperative Cognitive Dysfunction, POCD, Spinal Surgery, Sevoflurane, Propofol, General Anesthesia, 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.
Sevoflurane AdministrationDrug
Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Propofol AdministrationDrug
Intravenous anesthesia using propofol. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Experimental | Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE. Receives: Drug: Sevoflurane Administration |
| Propofol Group | Experimental | Patients in this group will receive general anesthesia using propofol during elective spinal surgery. Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) at 6 hours, 24 hours, 3 days, and 7 days after surgery. Receives: Drug: Propofol Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-Mental State Examination (MMSE) Score
Cognitive function of participants will be assessed using the Mini-Mental State Examination (MMSE) at multiple time points postoperatively. The change from baseline MMSE scores will be compared between the sevoflurane and propofol groups to evaluate the incidence and severity of postoperative cognitive dysfunction (POCD).
Measured: Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition / Focus: Postoperative Cognitive Dysfunction (POCD) Following Spinal SurgeryStudies 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
- Patients are randomly assigned to either the sevoflurane or propofol group. Cognitive function is assessed at multiple time points postoperatively using the MMSE.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isak Lambas, Universitas Sumatera Utara
- Investigators
- Isak Isak, MD, Principal investigator, Department of Anesthesiology and Intensive Therapy, University of North Sumatra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378878
- Sponsor's protocol ID
- 88/KEPK/USU/2025
- Acronym
- SEVO-PROP-MMSE
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Propofol Administration on Postoperative Cognitive Dysfunction in Spinal Surgery Using the Mini-Mental State Examination (MMSE)
- ClinicalTrials.gov ID
- NCT07378878
- Acronym / sponsor ID
- SEVO-PROP-MMSE / 88/KEPK/USU/2025
- Keywords
- Postoperative Cognitive Dysfunction, POCD, Spinal Surgery, Sevoflurane, Propofol, General Anesthesia, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 30 Jan 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 study aims to compare the effects of two commonly used anesthetic agents, sevoflurane and propofol, on cognitive function after spinal surgery. Postoperative cognitive dysfunction (POCD) is a common complication following general anesthesia, particularly in complex procedures such as spinal surgery. The Mini-Mental State Examination (MMSE) will be used to assess cognitive function before surgery and at multiple time points after surgery (6 hours, 24 hours, 3 days, and 7 days).
Twenty patients undergoing elective spinal surgery will be randomly assigned to receive either sevoflurane or propofol anesthesia. Cognitive outcomes will be measured and compared between the two groups. The study will evaluate whether propofol offers better preservation of cognitive function compared to sevoflurane, which has been associated with oxidative stress and hippocampal dysfunction.
The results of this study will provide important information for anesthesiologists and surgical teams regarding the choice of anesthetic agents to minimize cognitive decline after spinal surgery, improving patient safety and postoperative recovery.
Detailed description
Background:
Postoperative cognitive dysfunction (POCD) is a recognized complication following general anesthesia, particularly in major surgeries such as spinal procedures. POCD can affect memory, attention, and other cognitive domains, impacting patient recovery, quality of life, and independence after surgery. Sevoflurane, an inhalational anesthetic, has been associated with neurotoxic effects including oxidative stress and hippocampal dysfunction, which may contribute to POCD. Propofol, an intravenous anesthetic, exhibits antioxidative and anti-inflammatory properties, potentially offering neuroprotective effects.
Objective:
The primary objective of this study is to compare the incidence and severity of POCD in patients undergoing spinal surgery under sevoflurane versus propofol anesthesia, as assessed by the Mini-Mental State Examination (MMSE).
Methods:
This is a single-blind, randomized controlled trial involving 20 adult patients scheduled for elective spinal surgery at Universitas Sumatera Utara / RSUP H. Adam Malik Medan. Patients will be randomly allocated into two groups (n=10 per group) to receive either sevoflurane or propofol for general anesthesia.
Cognitive Assessment:
MMSE will be administered at the following time points:
Preoperatively (baseline)
6 hours postoperatively
24 hours postoperatively
3 days postoperatively
7 days postoperatively
Outcomes:
Primary Outcome: MMSE score change from baseline at each postoperative time point.
Secondary Outcomes: Incidence of mild or moderate POCD, defined according to MMSE decline; comparison of cognitive recovery trends between groups.
Statistical Analysis:
Descriptive statistics for demographic data.
Independent t-tests and chi-square tests to compare cognitive outcomes between groups.
Pearson correlation for analyzing associations between variables.
Significance threshold: p < 0.05.
Expected Results:
It is hypothesized that patients receiving propofol will demonstrate more stable MMSE scores postoperatively, whereas patients receiving sevoflurane may experience significant cognitive decline, particularly at 3 and 7 days after surgery.
Significance:
The study will provide evidence-based guidance for anesthetic selection in spinal surgery to minimize the risk of postoperative cognitive decline. This may improve patient recovery, satisfaction, and overall outcomes in surgical care.
Ethical Considerations:
The study has been approved by the Universitas Sumatera Utara Ethical Review Board (No. 88/KEPK/USU/2025). Informed consent will be obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to either the sevoflurane or propofol group. Cognitive function is assessed at multiple time points postoperatively using the MMSE.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Experimental | Drug: Sevoflurane AdministrationInhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE. |
| Propofol Group | Experimental | Drug: Propofol AdministrationPatients in this group will receive general anesthesia using propofol during elective spinal surgery. Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) at 6 hours, 24 hours, 3 days, and 7 days after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective spinal surgery.
- Age between 18 and 65 years.
- ASA (American Society of Anesthesiologists) physical status I-II.
- Able to give informed consent.
- Willing to participate in all cognitive assessments (MMSE) before and after surgery.
Key exclusion criteria (6 listed)
- History of neurological disorders (e.g., dementia, stroke, epilepsy).
- Severe psychiatric disorders.
- Known allergy or contraindication to sevoflurane or propofol.
- History of drug or alcohol abuse.
- Patients undergoing emergency spinal surgery.
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 |
|---|---|---|
| Sevoflurane AdministrationInhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE. | Drug | Sevoflurane Group |
| Propofol AdministrationIntravenous anesthesia using propofol. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE. | Drug | Propofol Group |
Primary outcome
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively
Cognitive function of participants will be assessed using the Mini-Mental State Examination (MMSE) at multiple time points postoperatively. The change from baseline MMSE scores will be compared between the sevoflurane and propofol groups to evaluate the incidence and severity of postoperative cognitive dysfunction (POCD).
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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
Isak Isak, MD principal investigator
Department of Anesthesiology and Intensive Therapy, University of North Sumatra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane Administration and Propofol Administration in people with Condition / Focus: Postoperative Cognitive Dysfunction (POCD) Following Spinal Surgery, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 5 inclusion and 6 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 30 Jan 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 Indonesia. 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?
Change in Mini-Mental State Examination (MMSE) Score (time frame: Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively). 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 30 Jan 2026.