COMPARISON OF SEVOFLURANE AND PROPOFOL ADMINISTRATION ON POSTOPERATIVE COGNITIVE DYSFUNCTION IN SPINAL SURGERY USING THE MINI-MENTAL STATE EXAMINATION (MMSE) (SEVO-PROP-MMSE)

January 22, 2026 updated by: Isak Lambas, Universitas Sumatera Utara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20155
        • RSUP H. Adam Malik Medan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane Group
Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Drug: Sevoflurane Administration
Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
Experimental: Propofol Group
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.
Drug: Propofol Administration
Intravenous anesthesia using propofol. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Isak Isak, MD, Department of Anesthesiology and Intensive Therapy, University of North Sumatra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88/KEPK/USU/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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