Dexmedetomidine and Magnesium Sulfate in the Reduction Cognitive Dysfunction in Geriatrics

NCT06702488 | Recruiting Phase 1 DMC

• 1 other identifier: R577
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Disorder

Keywords

Post-operative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

• the incidence of Post Operative Cognitive Dysfunction

  Post Operative Cognitive Dysfunction

  24 hours postoperative

Secondary Outcomes (1)

• CRP levels and their correlation with POCD

  24 hours of postoperative

Study Arms (2)

The dexmedetomidine

ACTIVE COMPARATOR

29 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.

Drug: dexmedetomidine

The magnesium sulfate

ACTIVE COMPARATOR

29 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

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

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.

Also known as: magnesium sulfate

The dexmedetomidine; The magnesium sulfate

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Dexmedetomidine

Al Fayyum, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 13243706 RESULT

MeSH Terms

Conditions

Mental Disorders

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Mohamed Ahmed Hamed, MD

CONTACT

01010509736; mah07@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 21, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)