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Mental DisorderPhase 1NCT06702488

Dexmedetomidine and Magnesium Sulfate in the Reduction Cognitive Dysfunction in Geriatrics

A Phase 1 study testing dexmedetomidine in people with Mental Disorder, run by Fayoum University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Magnesium sulfate is considered a neuroprotective drug and has been studied in various applications. Recently, it has drawn the attention of anesthesiologists, resulting in numerous publications about its role in anesthesiology. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Mental Disorder
What is being tested?
dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteEgypt
Study dates
21 Nov 2024to 15 May 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA physical status I, II and ⅠⅠⅠ
  • patients undergoing open abdominal surgery under general anesthesia

Who cannot join

  • Elderly patients with preoperative MoCA Score below 26.
  • Operation time more than 4 hours to prevent excessive dosage of magnesium sulfate.
  • BMI > 35 kg m-2

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Ahmed Hamed, MD contact

01010509736

mah07@fayoum.edu.eg

Egypt1 site, 1 recruiting
  • Dexmedetomidine

    Al Fayyum

    Recruiting

Other trials in Egypt

About this study

Official title: The Efficacy of Dexmedetomidine and Magnesium Sulfate in Cognitive Dysfunction

Magnesium sulfate is considered a neuroprotective drug and has been studied in various applications. Recently, it has drawn the attention of anesthesiologists, resulting in numerous publications about its role in anesthesiology.

Magnesium sulfate is suggested to exert its neuroprotective effect by preventing excitotoxicity. in the clinical setting, intraoperative magnesium sulfate attenuated POCD. Furthermore, postoperative emergence agitation was significantly reduced in pediatric patients who received intraoperative magnesium sulfate during adenotonsillectomy.

The aim of this study The aim of this work is to compare the protective effect of intraoperative dexmedetomidine with magnesium sulfate against developing POCD and to study their effect on serum level of CRP; the marker of neuronal degeneration.

Read the detailed description

Post-operative cognitive dysfunction (POCD) in the elderly, defined as alteration either in thinking and/or impaired higher mental functions following surgery and anesthesia.

POCD should be seriously concerned in elderly people during induction of general anesthesia because of its high overall incidence rate (25.8% at one week, 9.9% after 3 months) with increasing the risk for it as the age advances due to physiologic changes that occurs, such as greater sensitivity to anesthetic drugs, higher drug concentrations at central nervous system receptors .

The etiology and pathogenesis of POCD following general anesthesia has gained much attention in the last years. recent research reveals a significant postoperative elevation of the marker of neuronal degeneration; S100β protein.S100β protein is an acidic calcium binding protein, found in astrocytes and schwann cells. Physiological serum levels of S100β protein are low, but in the early stages of neuronal injury, S100β is released into the blood. evidence suggested that overexpressed S100B can promote Aβ generation from amyloid precursor protein.The increased Aβ and amyloid precursor protein are known to be associated with cognitive impairment.consequently, postoperative elevation of S100β can be considered one of the possible mechanisms involved in the etiopathogenesis of POCD.

Dexmedetomidine have recently become prominent due to their increased use in anaesthetic and critical care practice for sedation and analgesia. dexmedetomidine suppress the inflammatory markers that are usually elevated in the post-surgical period, as well as neuronspecific markers of inflammation like neuron specific enolase (NSE) and S-100β, compared to controls Dexmedetomidine, a dextro-enantiomer of medetomidine and a highly selective a2 adrenoreceptor agonist, has sedative, analgesic, and sympatholytic properties, thereby reducing the requirement for anesthetic agents. a2 adrenergic receptors are abundant in the dorsal noradrenergic bundles, locus coeruleus, and frontal lobe, which are crucial for cognitive function and selective attention. Zhang et al. reported that a 0.5 μg kg-1 loading dose over 10 minutes followed by an infusion dose of 0.5 μg kg-1 h-1 in elderly patients undergoing laparoscopic surgery under general anesthesia for colorectal cancer provided neuroprotection regarding the reduced incidence of POCD and neuroinflammatory marker levels. A meta-analysis also found that dexmedetomidine during surgery suppressed inflammatory cytokines, particularly IL-1 and IL-6, perioperatively and helped preserve cognitive functions in the elderly . It has been reported that postoperative elevation of peripheral C-reactive protein (CRP) and interleukin 6 concentrations is associated with higher risks of postoperative delirium.Interestingly, the authors also found that increased preoperative concentrations of CRP and interleukin 6 are also associated with an increased risk of postoperative delirium, thus supporting the hypothesis that preoperative pathologies may also contribute to the risk of subsequent postoperative delirium.

Conditions
Mental Disorder
Being tested
dexmedetomidine
Keywords
Post-operative cognitive dysfunction
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidineDrug

    Also called magnesium sulfate

    20 mg/kg as a loading dose over 10 minutes before induction then a maintenance dose of 5 mg/kg/hour, which will also be discontinued at the skin closure.

Study groups in NCT06702488
Study groupRoleWhat they receive
The dexmedetomidineActive comparator29 patients will receive a bolus dose of dexmedetomidine (0.5 μg kg-1) over 10 minutes before induction followed by an infusion (0.3 μg kg-1 h-1), which will be discontinued at the skin closure.
Receives: Drug: dexmedetomidine
The magnesium sulfateActive comparator29 patients will receive 20 mg/kg as loading dose over 10 minutes before induction then maintenance dose 5 mg/kg/hour, which will also be discontinued at the skin closure
Receives: Drug: dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of Post Operative Cognitive Dysfunction

    Post Operative Cognitive Dysfunction

    Measured: 24 hours postoperative

Secondary outcomes (1)
  1. CRP levels and their correlation with POCD

    CRP levels and their correlation with POCD

    Measured: 24 hours of postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start21 Nov 2024
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion15 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702488
Sponsor's protocol ID
R577
Status last verified
Nov 2024
First submitted
20 Nov 2024
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan to share

Publications

  • BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available.

    PubMed 13243706

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dexmedetomidine in people with Mental Disorder, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Ahmed Hamed, MD (01010509736, mah07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of Post Operative Cognitive Dysfunction (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06702488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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