COMPARISON OF SEVOFLURANE AND PROPOFOL ADMINISTRATION ON POSTOPERATIVE COGNITIVE DYSFUNCTION IN SPINAL SURGERY USING THE MINI-MENTAL STATE EXAMINATION (MMSE)
SEVO-PROP-MMSE
Comparison of Sevoflurane and Propofol Administration on Postoperative Cognitive Dysfunction in Spinal Surgery Using the Mini-Mental State Examination (MMSE)
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2025
CompletedFirst Submitted
Initial submission to the registry
January 22, 2026
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedJanuary 30, 2026
January 1, 2026
3 months
January 22, 2026
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively
Study Arms (2)
Sevoflurane Group
EXPERIMENTALInhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Propofol Group
EXPERIMENTALPatients 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.
Interventions
Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Intravenous anesthesia using propofol. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RSUP H. Adam Malik Medan
Medan, North Sumatra, 20155, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isak Isak, MD
Department of Anesthesiology and Intensive Therapy, University of North Sumatra
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants are aware of the anesthesia type, but outcome assessors performing MMSE tests are blinded to the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - Department of Anesthesiology and Intensive Therapy, Universitas Sumatera Utara
Study Record Dates
First Submitted
January 22, 2026
First Posted
January 30, 2026
Study Start
February 1, 2025
Primary Completion
May 15, 2025
Study Completion
May 15, 2025
Last Updated
January 30, 2026
Record last verified: 2026-01