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Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT05341154
Recruitment Status : Recruiting
First Posted : April 22, 2022
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Huda Fahmy Mahmoud, PhD, Aswan University Hospital

Tracking Information
First Submitted Date  ICMJE April 17, 2022
First Posted Date  ICMJE April 22, 2022
Last Update Posted Date April 22, 2022
Actual Study Start Date  ICMJE December 1, 2021
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2022)
  • Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score [ Time Frame: 72 hours ]
    Mini Mental State Examination (MMSE) score < 24 points
  • Postoperative delirium by Delirium Observation Screening Scale (DOS) [ Time Frame: 72 hours ]
    ≥3 points
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2022)
  • postoperative cortisol level [ Time Frame: 24 hour ]
    Blood for preoperative cortisol level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery
  • postoperative CRP level [ Time Frame: 24 hour ]
    Blood for preoperative CRP level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium
Official Title  ICMJE Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Emergency Surgery: A Comparative Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Emergence Delirium
Intervention  ICMJE Drug: Ketamine Hcl 50Mg/Ml Inj
Patients will be given the active comparator or placebo only once right before the induction of anesthesia.
Other Name: Dexmedetomidine 1000 mcg/ml inj
Study Arms  ICMJE
  • 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:

    1. Induction with propofol (1-2 mg/kg body weight).
    2. Esmeron (1 mg/kg body weight).
    3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.
    4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.
    5. 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.
    Intervention: Drug: Ketamine Hcl 50Mg/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:

    1. Induction with propofol (1-2 mg/kg body weight).
    2. Esmeron (1 mg/kg body weight).
    3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.
    4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.
    5. 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.
    Intervention: Drug: Ketamine Hcl 50Mg/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:

    1. Induction with propofol (1-2 mg/kg body weight).
    2. Esmeron (1 mg/kg body weight).
    3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.
    4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.
    5. 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.
    Intervention: Drug: Ketamine Hcl 50Mg/Ml Inj
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) ≥3 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: huda fahmy, phD 01098887555 huda.fahmy@aswu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05341154
Other Study ID Numbers  ICMJE 548 / 7 / 2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Huda Fahmy Mahmoud, PhD, Aswan University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Huda Fahmy Mahmoud, PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tarek Sayed, lecturer Aswan University
PRS Account Aswan University Hospital
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP