Quetiapine as Prophylaxis for Delirium in CABG

NCT05801289 | Unknown

• 1 other identifier: R 293/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

low-dose quetiapine may be effective in preventing delirium in patients. The purpose of this study is to evaluate the efficacy and safety of quetiapine for delirium prophylaxis in cabg

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• delirium incidence

  CAM\_ICU

  3 days postoperative

Secondary Outcomes (6)

• days without delirium

  5 days postoperative

• duration of delirium if it appear

  7 days postoperative

• severity of delirium

  7 days postoperative

• length of stay in the ICU

  3 days postoperative

• the length of stay in the hospital

  7 days postoperative

Study Arms (2)

Group Q

ACTIVE COMPARATOR

will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative

Drug: Quetiapine

Group C

NO INTERVENTION

will receive placebo alone

Interventions

Quetiapine DRUG

Giving the drug to group Q

Also known as: Seroquel

Group Q

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 65 or older old of age undergoing open heart surgery and having an equal or greater score of 5 on the scale of Delphi.
• Age: 70-79 years: 1 point; ≥ 80 years: 2 points
• Physical activity: need for assistance, not self-sufficient: 2 points
• Alcoholism: 1 point
• Hearing impaired: 1 point
• History of delirium: 2 points
• Emergency of surgery: 2 points
• No laparoscopic surgery: 2 points
• Admission critical unites: 3 points
• Value of C reactive protein (CRP) ≥ 10mg/dl: 1 point

You may not qualify if:

• Patient refusal.
• Allergy to quetiapine
• Patients with a score less than 5 on Delphi scale
• Diagnosis of delirium on admission initial CAM-ICU (the Confusion Assessment Method-ICU) positive)
• Could not communicate due to previously diagnosed irreversible neurologic disease (stroke, cerebral hemorrhage, traumatic brain injury, dementia, etc.)
• High risk for ventricular arrhythmias (Corrected QT interval ≥ 460 millisecond in men, ≥ 470 millisecond in women or ongoing treatment with drugs known to prolong the QT interval (e.g., erythromycin, class Ia, Ic, III anti-arrhythmic drugs)
• Second or third degree heart block
• High risk for drug interaction with quetiapine (phenytoin, carbamazepine, barbiturates)
• Electrolyte disturbance : Potassium less than 3 or magnesium less than 1.5
• Patient on antipsychotic drug treatment prior to admission
• Parkinson's disease

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

wael abdelmoneim, MD

CONTACT

01224576517; waelelswefi@med.asu.edu.eg

MOHAMED S SHORBAGY, MD

CONTACT

01227528857; dr.mohammedelshorbagy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 6, 2023
• Study Start: December 4, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

EG (1)