NCT07424729

Brief Summary

Purpose: Postoperative cognitive dysfunction (POCD) is a common complication in elderly patients following major surgery and is associated with impaired attention, memory, and executive functions. Advanced age and prolonged surgical duration are among the most important risk factors. Minimal flow anesthesia has been suggested to reduce postoperative cognitive impairment by providing more stable anesthetic depth and reducing physiological stress. The aim of this study is to investigate the relationship between surgical duration and postoperative cognitive dysfunction in elderly patients undergoing surgery under minimal flow anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 3, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

February 5, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Postoperative cognitive dysfunctionMinimal flow anesthesiaElderly patientsMini-Mental State ExaminationSurgical duration

Outcome Measures

Primary Outcomes (1)

  • Change in Mini-Mental State Examination score

    Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a 30-point scale ranging from 0 to 30, where higher scores indicate better cognitive function. The primary outcome is the change in MMSE score between the preoperative assessment and postoperative assessments. Change in cognitive function assessed by the difference between preoperative and postoperative Mini-Mental State Examination scores.

    Preoperative baseline, postoperative 24 hours, and postoperative day 7

Secondary Outcomes (1)

  • Incidence of postoperative cognitive dysfunction

    Postoperative 24 hours and postoperative day 7

Study Arms (2)

Arm 1: Surgery duration <2 hours

EXPERIMENTAL

Elderly patients undergoing surgery under minimal flow anesthesia with a surgical duration of less than 2 hours. Cognitive function will be assessed preoperatively and postoperatively using the Mini-Mental State Examination.

Other: Mini-Mental State Examination

Arm 2: Surgery duration ≥2 hours

EXPERIMENTAL

Elderly patients undergoing surgery under minimal flow anesthesia with a surgical duration of 2 hours or longer. Cognitive function will be assessed preoperatively and postoperatively using the Mini-Mental State Examination.

Other: Mini-Mental State Examination

Interventions

Cognitive function will be assessed using the Mini-Mental State Examination preoperatively and at postoperative time points.

Also known as: MMSE
Arm 1: Surgery duration <2 hoursArm 2: Surgery duration ≥2 hours

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged between 65 and 85 years
  • ASA physical status I-III
  • Scheduled for elective surgery under general anesthesia in general surgery or otorhinolaryngology operating rooms
  • Planned to receive minimal flow general anesthesia
  • Preoperative Mini-Mental State Examination performed
  • Able to provide informed consent

You may not qualify if:

  • Age outside the specified range
  • ASA physical status IV or higher
  • Severe comorbid disease affecting perioperative stability
  • Surgery performed under regional anesthesia
  • History of alcohol, drug, or substance abuse
  • Significant visual or hearing impairment interfering with cognitive testing
  • Refusal to participate
  • Known neurological or psychiatric disorders
  • Preoperative MMSE score below 24
  • Perioperative hemodynamic instability
  • Illiteracy preventing completion of cognitive tests
  • Postoperative admission to intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

Related Publications (1)

  • Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the Nomenclature of Cognitive Change Associated with Anaesthesia and Surgery-2018. Anesthesiology. 2018 Nov;129(5):872-879. doi: 10.1097/ALN.0000000000002334.

    PMID: 30325806BACKGROUND

Related Links

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • oya çimen, MD

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors performing the cognitive evaluations will be blinded to surgical duration and intraoperative management.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be assigned into two parallel groups according to surgical duration (less than 2 hours or longer) and postoperative cognitive outcomes will be compared between groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 20, 2026

Study Start

October 3, 2025

Primary Completion

March 12, 2026

Study Completion

March 15, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves a single-center academic dataset and no data-sharing agreement has been established. De-identified data may be made available upon reasonable request to the principal investigator.

Available IPD Datasets

Study Protocol Access

Locations