To compare the effect of two doses of tablet melatonin on occurrence of ICU delirium
Phase 3
- Conditions
- Health Condition 1: F05- Delirium due to known physiological condition
- Registration Number
- CTRI/2024/05/067172
- Lead Sponsor
- Vardhman Mahavir Medical College and Safdarjung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Preserved oral/enteral intake within the first 48 hours of ICU admission.
2. Patients requiring an ICU stay of at least 5 days.
3. Richmond Agitation Sedation Scale (RASS) score within + 2 or - 2 on admission
Exclusion Criteria
1. Hemodynamically unstable patients or on vasopressor support
2. Patients on psychotropic medications or having known psychiatric illness
3. Patients with debilitating neurological diseases and low GCS less than 10 on admission
4. Pregnant patients
5. Patient with known or suspected allergy to melatonin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of deliriumTimepoint: Twice a day once at 9 am and after giving the melatonin tablet at 9pm for a period of 5 days
- Secondary Outcome Measures
Name Time Method 1. To compare length of Intensive Care Unit stay in 2 study groups. <br/ ><br>2. To compare the incidence of headache, dizziness and day-time sleepiness between the <br/ ><br>two study groups.Timepoint: At the end of their hospital stay