- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07392840
Postoperative Cognitive Dysfunction in Elderly and it's Relation With Sleep Disorders and Melanin Concentrating Hormone
Postoperative Delayed Neurocognitive Recovery in Elderly Patients Undergoing Spinal Anesthesia: Assessment of Its Prevalence and Correlation With Preoperative Sleep Disorders and Melanin Concentrating Hormone.
Study Overview
Status
Conditions
Detailed Description
Perioperative neurocognitive disorders (PNDs) have gradually become a priority during the perioperative period, including neurocognitive disorder before surgery, delirium and delayed neurocognitive recovery (DNR) within 30 days after surgery, and postoperative neurocognitive disorder up to 12 months after surgery. The incidence of DNR ranges from 9.1% to 45%, which seriously affects the perioperative brain health of older adult patients .
The increasing aging population and the reduced function and compensatory capacity of various systems in elderly patients also significantly increase the risk of cognitive dysfunction .
Sleep disorders are critical risk factors among the various risk factors for DNR after surgery. Meanwhile, aging is an independent risk factor for sleep disorders .
Therefore, it is clinically significant to conduct early cognitive risk prediction, focusing on older adult patients with preoperative sleep disorders. Studies have explored the risk factors for perioperative sleep disorders, while other studies have also explored the risk factors affecting postoperative cognitive outcomes. However, no study has explored the specific risk factors for DNR in patients with preoperative sleep disorders. Considering the relationship between sleep and postoperative cognitive function, especially in older adult patients, it is necessary to link these 2 main risk factors (preoperative sleep disorders and DNR) that impair the perioperative brain health to explore potential biomarkers .
Melanin-concentrating hormone (MCH) is a highly conserved cyclic neuropeptide with 19 amino acids in mammals and has a variety of physiological functions, including orexigenic properties, energy homeostasis, regulation of moods, sleep, wakefulness, and cognitive functions .
Melanin-concentrating hormone (MCH) can enhance synaptic plasticity in the hippocampus, which plays an important role in maintaining cognitive function In addition to regulating synaptic plasticity, MCH can also regulate cognitive functions such as learning and memory by regulating rapid eye movement (REM) sleep and acetylcholine outflow in the hippocampus .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed Yasein Mohamed, Assistant lecturer
- Phone Number: +20 01016383701
- Email: myasein76@yahoo.com
Study Contact Backup
- Name: Mohamed Mostafa Ali, MD
- Phone Number: +201009650970
- Email: drzahrawy3@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients of both genders ageing 65 years or above.
- ASA grade I to III.
- Undergo elective lower limb surgery under spinal anesthesia
- Agree to collect one's own CSF and blood samples
Exclusion Criteria:
- Past history of depression,anxiety,delirium and schizophrenia .
- Past history of drug dependence.
- Past history of dementia,including Alzheimer disease(AD).
- Preoperative Montreal Cognitive Assessment (MoCA) score <26.
- Inability to understand or cooperate with the evaluation scale or questionnaire.
- Refuse collecting one's own CSF and blood samples.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group A
25 patients with preoperative sleep disorders
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Group B
25 patients without preoperative sleep disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To investigate the impact of preoperative sleep problems as indicators of delayed neurocognitive recovery (DNR) in elderly adults following spinal anesthesia.
Time Frame: Baseline, one week, three months
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By comparison between the two groups
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Baseline, one week, three months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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to investigate the predictive power of CSF and plasma MCH levels for delayed neurocognitive recovery (DNR) in older adults after spinal anesthesia
Time Frame: Baseline one day before operation
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Baseline one day before operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Mostafa Ali, MD, El-minya University Hospital
Publications and helpful links
General Publications
- Wagner S, Ahrens E, Wachtendorf LJ, et al. Association of obstructive sleep apnea with postoperative delirium in procedures of moderate-to-high complexity: a hospital-registry study. Anesth Analg. 2023.
- Travica N, Lotfaliany M, Marriott A, et al. Peri-operative risk factors associated with post-operative cognitive dysfunction (POCD): an umbrella review of meta-analyses of observational studies. J Clin Med. 2023;12:1610.
- POIRIER, Gabriel, et al. Deterioration, compensation and motor control processes in healthy aging, mild cognitive impairment and Alzheimer's disease. Geriatrics, 2021, 6.1: 33
- Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev.2013;17:293-298. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699.
- Li Yun,Zhang Xizhe, et al . Research progress on the role of melanin-concentrating hormone system in sleep deprivation -induced impairment of learning and memory function [ J ] . International Journal of Anesthesiology and Resuscitation , 2022 , 43 ( 10 ): 1117-1120 .
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res.1989;28:193-213.
- Butris N, Tang E, Pivetta B, et al. The prevalence and risk factors of sleep disturbances in surgical patients:a systematic review and meta-analysis. Sleep Med Rev.2023;69:101786.
- Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699.
- Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev.2013;17:293-298.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Postop. cognitive dysfunction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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