Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

NCT05341154 | Completed

• 1 other identifier: 548 / 7 / 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Ketamine group

ACTIVE COMPARATOR

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.

Drug: Ketamine Hcl 50Mg/Ml Inj

Dexmedetomidine group

ACTIVE COMPARATOR

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.

Drug: Ketamine Hcl 50Mg/Ml Inj

Placebo group

PLACEBO COMPARATOR

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.

Drug: Ketamine Hcl 50Mg/Ml Inj

Interventions

Ketamine Hcl 50Mg/Ml Inj DRUG

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

Also known as: Dexmedetomidine 1000 mcg/ml inj

Dexmedetomidine group; Ketamine group; Placebo group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 65 years. 2- Scheduled for visceral, orthopedic, vascular, obstetric, urology, or plastic surgery.

You may not qualify if:

• Delirium upon hospital admission or development of delirium prior to surgery stated by family members.
• 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

Sponsors & Collaborators

• Huda Fahmy Mahmoud, PhD: lead

Study Sites (1)

Huda Fahmy Mahmoud

Aswān, 81511, Egypt

Location

Related Publications (1)

• Ghazaly HF, Hemaida TS, Zaher ZZ, Elkhodary OM, Hammad SS. A pre-anesthetic bolus of ketamine versus dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing emergency surgery: a randomized, double-blinded, placebo-controlled study. BMC Anesthesiol. 2023 Dec 11;23(1):407. doi: 10.1186/s12871-023-02367-8.

  PMID: 38082227 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tarek Sayed, lecturer

  Aswan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 22, 2022
• Study Start: December 1, 2021
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)