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Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

Primary Purpose

Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine Hcl 50Mg/Ml Inj
Sponsored by
Huda Fahmy Mahmoud, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huda Fahmy Mahmoud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ketamine group

Dexmedetomidine group

Placebo group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score
Mini Mental State Examination (MMSE) score < 24 points
Postoperative delirium by Delirium Observation Screening Scale (DOS)
>4 points

Secondary Outcome Measures

Full Information

First Posted
April 17, 2022
Last Updated
May 6, 2023
Sponsor
Huda Fahmy Mahmoud, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT05341154
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
May 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huda Fahmy Mahmoud, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hcl 50Mg/Ml Inj
Other Intervention Name(s)
Dexmedetomidine 1000 mcg/ml inj
Intervention Description
Patients will be given the active comparator or placebo only once right before the induction of anesthesia.
Primary Outcome Measure Information:
Title
Postoperative cognitive impairment by Mini Mental State Examination (MMSE) score
Description
Mini Mental State Examination (MMSE) score < 24 points
Time Frame
72 hours
Title
Postoperative delirium by Delirium Observation Screening Scale (DOS)
Description
>4 points
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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) ≥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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Sayed, lecturer
Organizational Affiliation
Aswan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huda Fahmy Mahmoud
City
Aswan
ZIP/Postal Code
81511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

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