Evaluation of the role of melatonin as a potential drug for prevention of delirium in patients who have been operated and are admitted in the intensive care unit.
Phase 3
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/02/031183
- Lead Sponsor
- Dr Kriti Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Postoperative patients who are going to be ventilated more than 48 hours in the trauma ventilatory unit.
2. Adults (20years - 60 years) able to receive medication enterally (oral or via nasogastric tube) during first 48 hours of admission
Exclusion Criteria
â??Not giving consent
â??Sensitivity or history of allergic reaction to melatonin supplement,
â??Pregnant
â??Patients with paralytic ileus.
â??Patient having expected stay or life expectancy of less than 48 hours
â??Preexisting Premorbid pathologies particularly cognitive dysfunction, dementia, psychiatric disorders or sleep disorders
â??Patients with history of head injury , substance abuse or withdrawal.
â??Patients with Hearing impairments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method On the day of discharge/transfer patient will be assessed using the CAM-ICU (Confusion Assessment Method) scale. <br/ ><br> <br/ ><br>ï?¼The patients will be categorized as â??Deliriousâ?? or â??Not Deliriousâ?? on the basis of the results from the CAM-ICU scale and results will be analyzed. <br/ ><br>Timepoint: from admission into ICU to discharge from IC
- Secondary Outcome Measures
Name Time Method ATimepoint: NA