Quetiapine in Prevention of Delirium

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05793632

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: Quetiapine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk

Actual Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine The patients with multiple risks for delirium will receive 25 mg/day PO	Drug: Quetiapine The patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes.
No Intervention: Non pharmacological preventive bundle The patients will only be monitored with application of delirium preventive bundle without pharmacological agent

Arm

Intervention/Treatment

Experimental: Quetiapine

The patients with multiple risks for delirium will receive 25 mg/day PO

Drug: Quetiapine

The patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes.

No Intervention: Non pharmacological preventive bundle

The patients will only be monitored with application of delirium preventive bundle without pharmacological agent

Outcome Measures

Primary Outcome Measures

Quetiapine in preventing delirium [2 months]
The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score >5 = severe delirium)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with anemia
Sedated patients
Hypotensive patients
Immobilized patients
Patients with visual or auditory impairment

Exclusion Criteria:

Patients or guardians refuse to participate
Patients diagnosed with delirium
Contraindication for delirium

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Walid Kamel, Faculty of medicine, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05793632

Other Study ID Numbers:

Quetiapine

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Quetiapine Fumarate

Study Results

No Results Posted as of Mar 31, 2023