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Completed

NCT Number: NCT05341154

Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huda Fahmy Mahmoud

Aswān, 81511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hcl 50Mg/Ml Inj

Drug

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

Other names: Dexmedetomidine 1000 mcg/ml inj

Primary outcomes

  1. Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score

    Time frame: 72 hours

    Mini Mental State Examination (MMSE) score < 24 points

  2. Postoperative delirium by Delirium Observation Screening Scale (DOS)

    Time frame: 72 hours

    >4 points

Sponsors and collaborators

Lead sponsor

Huda Fahmy Mahmoud, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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