Quetiapine as Prophylaxis for Delirium in CABG

Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries

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

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Drug: Quetiapine

Detailed Description

Group Q: will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative (30 patients).

Group C: will receive placebo alone (30 patients). During the study period, enrolled patients will be assessed for delirium once daily (from 7:00 AM to 7:00 PM), and the assessment will be performed in two steps. First, level of sedation will be assessed using the RASS. If the patient will be deeply sedated or unarousable (RASS -4 or -5), the assessment will not be performed and the patient will be reassessed at a later time. If the patient has a RASS of -3to +4, then the assessment will be continued to the next step.

Second, delirium will be diagnosed using the CAM-ICU. The screening tool detects four features of delirium: acute onset of mental status change or a fluctuating course, inattention, disorganized thinking, and altered level of consciousness. To have delirium diagnosed, a patient displays the first two features with either the third or fourth feature.

The primary outcome is delirium incidence diagnosed with the CAM_ICU within the study period. If the CAM_ICU is positive at least once during the study period, it will be recorded that a delirium occurred.

Secondary outcomes is the rate of positive CAM-ICU (the number of positive CAM-ICU counts/the number of total CAM-ICU counts), days without delirium (number of days from the start of treatment until delirium), the duration of delirium if it appear (number of days with delirium), severity of delirium as measured with delirium rating scale revised 98 (DRS-R-89), the length of stay in the ICU, the length of stay in the hospital, the duration of intubation, a successful extubation, the ICU mortality, the overall mortality, measurement of QTc prolongation, and the use of rescue medication.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wael abdelmoneim, MD; Phone Number: 202 01224576517; Email: waelelswefi@med.asu.edu.eg
• Study Contact Backup: Name: MOHAMED S SHORBAGY, MD; Phone Number: 202 01227528857; Email: dr.mohammedelshorbagy@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Osama Ibrahim Mansour, MD; Phone Number: 202 26857539; Email: Vice.research@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Q; will receive 25 mg quetiapine at night of surgery and 25 mg daily for 7 days postoperative	Drug: Quetiapine; Giving the drug to group Q; Other Names: Seroquel
No Intervention: Group C; will receive placebo alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium incidence	CAM_ICU	3 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
days without delirium	days	5 days postoperative
duration of delirium if it appear	days	7 days postoperative
severity of delirium	DRS-R-89	7 days postoperative
length of stay in the ICU	days	3 days postoperative
the length of stay in the hospital	days	7 days postoperative
the ICU mortality	number	3 days postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: R 293/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No