the effect of melatonin for the management of delirium and agitatio

Phase 3

Not yet recruiting

• Conditions: Condition 1: Delirium. Condition 2: Agitation.; Delirium due to known physiological condition; Restlessness and agitation; R45.1

• Registration Number: IRCT20150221021159N8
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Age 18 years or older
Hospitalization in the intensive care unit with delirium receiving quetiapine
Normal gastrointestinal function to receive medication by the mouth or other enteral routes
Capability to follow the patient for at least 7 days
Full consent and acceptance of the patient or their legal guardian to recruit in the study

Exclusion Criteria

Patients with GCS= 8
History of severe melatonin allergy
History of epilepsy or seizures
Chronic heart failure ( New York Heart Association classification III/IV )
The patient's Richmond Agitation-Sedation Scale (RASS) is about -4 or -5
Head trauma
History of delirium or mood changes before admission to the IC

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of patient's delirium. Timepoint: Daily from the beginning of the study. Method of measurement: CAM-ICU questionnaire for delirium.;Agitation. Timepoint: Daily from the beginning of the study. Method of measurement: Richmond agitation sedation scale score.