Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

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

Tracking Information

• First Submitted Date: April 17, 2022
• First Posted Date: April 22, 2022
• Last Update Posted Date: April 22, 2022
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: May 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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  Blood for preoperative cortisol level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery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  Blood for preoperative CRP level measurement will be withdrawn directly before anesthesia induction and was withdrawn between 6 a.m. and 8 a.m. on the first morning after surgery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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Emergence Delirium

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 17, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2022
• Estimated Primary Completion Date: May 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 65 Years to 80 Years (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: huda fahmy, phD; 01098887555; huda.fahmy@aswu.edu.eg

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05341154
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Huda Fahmy Mahmoud, PhD, Aswan University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Huda Fahmy Mahmoud, PhD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tarek Sayed, lecturer; Aswan University

• PRS Account: Aswan University Hospital
• Verification Date: April 2022