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Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Emergency Surgery: A Comparative Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05341154
Enrollment
60
Registered
2022-04-22
Start date
2021-12-01
Completion date
2023-05-06
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Brief summary

Delirium is a common postoperative complication in the elderly, often caused by multiple factors. It is defined as an acute neuropsychiatric disorder characterized by fluctuating disturbances in attention, awareness, and cognition. Postoperative delirium occurs in 17-61% of the major surgical procedures. It may be associated with cognitive decline, decreased functional independence, increased risk of dementia, caregiver burden, health care costs, morbidity, and mortality. Therefore, delirium is a possibly disastrous condition and is both a huge burden on a patient's health and on the health care system in general.

Detailed description

Over the last few decades, numerous risk factors for delirium have been identified, emphasizing the importance of delirium prevention in patients undergoing surgery. It has already been identified as a state that may be associated with serious complications such as prolonged ICU and hospital stays, decreased quality of life, and increased mortality ). Previous studies on delirium pointed out old age and other factors as important predisposing factors. on the health care system in general. Extensive research on reducing the incidence of delirium has been conducted using both pharmacological and non-pharmacological preventive measures in the acute setting. As evidence recommending or opposing specific drugs for the prevention of postoperative delirium remains insufficient and the international guidelines can only recommend perioperative pharmacologic adjustments (American Geriatrics Society Abstracted Clinical Practice Guideline for Postoperative Delirium in Older Adults, 2015) . Consequently, the challenge of developing reliable hospital algorithms for delirium prevention and treatment remains unresolved. Furthermore, there is a link between postoperative delirium and two biomarkers, cortisol and C- Reactive Protein (CRP), which have previously been linked to delirium but whose significance is unknown.

Interventions

Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Sponsors

Huda Fahmy Mahmoud, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

An anesthesiologist who is not involved in the study will prepare the intervention (ketamine, dexmedetomidine, or placebo) in a standardized syringe with the same volume. Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 1- Patients aged ≥ 65 years. 2- Scheduled for visceral, orthopedic, vascular, obstetric, urology, or plastic surgery.

Exclusion criteria

* 1- Delirium upon hospital admission or development of delirium prior to surgery stated by family members. 2- Mini-Mental State Examination (MMSE) score \< 24 points 3- Delirium Observation Scale (DOS) ≥4 points 4- preoperative neurological diseases affecting cognitive function (such as vascular dementia) 5- High risk for postoperative treatment in the intensive care unit (ICU) 6- Known to have dexmedetomidine and or ketamine intolerance. 7- Lack of cooperation or communication. 8- Parkinson's disease, parkinsonism, intake of dopaminergic drugs (levodopa, dopamine agonists) 9- Epilepsy. 10- Patients on steroid therapy 11- severe liver and renal insufficiency

Design outcomes

Primary

MeasureTime frameDescription
Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score72 hoursMini Mental State Examination (MMSE) score \< 24 points
Postoperative delirium by Delirium Observation Screening Scale (DOS)72 hours\>4 points

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026