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Not yet recruiting NCT07310043

Creatine and Perioperative Brain Health

No phase Interventional Neurocognitive Disorders Postoperative Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Creatine monohydrate, Placebo.
Who it may be relevant to
Registry conditions: Neurocognitive Disorders, Postoperative Delirium. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Creatine Intervention in Older Adults to Improve Perioperative Brain Health

Overview

The overall goal of this study is to evaluate the feasibility of perioperative oral creatine supplementation and to explore its effects on cognitive function and physiological responses to surgery in older adults. Creatine is commonly used to enhance athletic performance, but it can also have positive effects on the brain. Since surgery can alter thinking, memory, and attention patterns in some patients, we will assess whether creatine affects these changes in older adults undergoing surgery.

Detailed description

Surgical interventions, while often necessary, are associated with substantial postoperative morbidity, particularly among older adults. Perioperative neurocognitive disorders (PND), characterized by changes in memory patterns in the perioperative period, are among the most common surgical complications in aging populations. Beyond their considerable economic burden, estimated to exceed $30 billion annually, PND imposes profound immediate consequences for patients and caregivers and is associated with long-term adverse outcomes, including an increased risk of dementia. Despite their high prevalence and clinical impact, effective, scalable, and easily implementable preventive strategies for PND remain limited.

Creatine plays a critical role in supporting the brain's high metabolic demands, and its homeostasis may be disrupted during periods of physiological stress such as anesthesia and surgery. Creatine supplementation has been demonstrated to be neuroprotective in high-stress conditions. However, the potential effects of creatine during perioperative cognitive vulnerability have not been previously investigated. This study will evaluate the feasibility of creatine supplementation in the perioperative period and explore its effects on cognitive function and physiological responses to surgery in older adults.

Interventions

  • Dietary supplement Creatine monohydrate
    Participants will receive creatine supplementation before surgery
  • Other Placebo
    Participants in the placebo group will receive an identical placebo before surgery

Primary outcome measures

  • Preoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Time frame: Within three weeks before surgery]
  • Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Time frame: Within one month after surgery]
  • Postoperative cognitive function assessed with the Montreal Cognitive Assessment (MoCA) [Time frame: Within three months after surgery]
  • Postoperative delirium assessed with the Confusion Assessment Method (CAM) [Time frame: Up to 7 days after surgery]

Eligibility criteria

Inclusion criteria

  • Patients scheduled for elective surgery under general anesthesia

Exclusion criteria

  • History of creatine deficiency disorders
  • Renal or neurodegenerative disorders
  • History of stroke or significant head trauma, presence of intracranial mass lesions
  • Inability to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07310043 · 2025P002111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗