NCT07378878

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Keywords

Postoperative Cognitive DysfunctionPOCDSpinal SurgerySevofluranePropofolGeneral AnesthesiaCognitive Function

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

EXPERIMENTAL

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

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.

Drug: Propofol Administration

Interventions

Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.

Sevoflurane Group

Intravenous anesthesia using propofol. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.

Propofol Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Isak Isak, MD

    Department of Anesthesiology and Intensive Therapy, University of North Sumatra

    PRINCIPAL INVESTIGATOR

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
Model Details: Patients are randomly assigned to either the sevoflurane or propofol group. Cognitive function is assessed at multiple time points postoperatively using the MMSE.
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

Locations