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.

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Drug: Ketamine Hcl 50Mg/Ml Inj

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81511
    • Huda Fahmy Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketamine group; An anesthesiologist who is not involved in the study will prepare the intervention, ketamine1 mg/kg BW, 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. All patients will be received standardized GA protocol as follows: Induction with propofol (1-2 mg/kg body weight).; Esmeron (1 mg/kg body weight).; Isoflurane is a volatile anesthetic agent in 50% O2 and air.; Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.; All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.	Drug: Ketamine Hcl 50Mg/Ml Inj; Patients will be given the active comparator or placebo only once right before the induction of anesthesia.; Other Names: Dexmedetomidine 1000 mcg/ml inj
Active Comparator: Dexmedetomidine group; An anesthesiologist who is not involved in the study will prepare the intervention, Dexmedetomidine 1 μg/kg BW, 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. All patients will be received standardized GA protocol as follows: Induction with propofol (1-2 mg/kg body weight).; Esmeron (1 mg/kg body weight).; Isoflurane is a volatile anesthetic agent in 50% O2 and air.; Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.; All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.	Drug: Ketamine Hcl 50Mg/Ml Inj; Patients will be given the active comparator or placebo only once right before the induction of anesthesia.; Other Names: Dexmedetomidine 1000 mcg/ml inj
Placebo Comparator: Placebo group; An anesthesiologist who is not involved in the study will prepare the intervention, normal saline 0.9% 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. All patients will be received standardized GA protocol as follows: Induction with propofol (1-2 mg/kg body weight).; Esmeron (1 mg/kg body weight).; Isoflurane is a volatile anesthetic agent in 50% O2 and air.; Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.; All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.	Drug: Ketamine Hcl 50Mg/Ml Inj; Patients will be given the active comparator or placebo only once right before the induction of anesthesia.; Other Names: Dexmedetomidine 1000 mcg/ml inj

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score	Mini Mental State Examination (MMSE) score < 24 points	72 hours
Postoperative delirium by Delirium Observation Screening Scale (DOS)	>4 points	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative cortisol level	Blood for preoperative cortisol level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery	24 hour
postoperative CRP level	Blood for preoperative CRP level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery	24 hour

Collaborators and Investigators

• Sponsor: Huda Fahmy Mahmoud, PhD
• Investigators: Principal Investigator: Tarek Sayed, lecturer, Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: 548 / 7 / 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No