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Clinical Trials/CTRI/2025/03/083309
CTRI/2025/03/083309
Not yet recruiting
Phase 4

To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing postoperative delirium in elderly patients undergoing cardiac surgery -A prospective randomised interventional study.

Sree chitra tirunal institute for medical sciences and technology1 site in 1 country134 target enrollmentStarted: April 20, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Sree chitra tirunal institute for medical sciences and technology
Enrollment
134
Locations
1
Primary Endpoint
To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing incidence of postoperative delirium in elderly patients undergoing cardiac surgery and to identify the agent that provides superior delirium prevention outcomes.

Overview

Brief Summary

Delirium is a brain dysfunction characterized by an acute onset and fluctuating disturbance in consciousness, attention and cognition. Postoperative delirium (POD) is a neuropsychiatric syndrome characterized by disturbances of cognition, attention, consciousness, or perception with  acute onset and fluctuating course.The incidence of POD in older individuals is 15% to 53%, most frequently occurring in the first 3 days after the procedure.Postoperative delirium (POD) is associated with poor outcomes, including prolonged hospital stay, increased costs, and worsened quality of life.Current interventions for delirium prevention primarily involve recognition and improvement of modifiable risk factors besides active treatment of original diseases, but the curative effect is not obvious. Within current guidelines, no pharmacological methods were recommended for delirium prevention. After cardiac surgery, delirium remains the most common neurocognitive complication with an incidence of  6-46% . Patients who have cardiac surgery are at higher risk of postoperative delirium than those following noncardiac surgery because of a higher prevalence of risk factors, such as older age, cerebrovascular disease, diabetes mellitus, and renal disease and receipt of cardiopulmonary bypass.Dexmedetomidine and melatonin have both shown promise in preventing delirium in various patient populations. However, there is a lack of comparative studies evaluating the efficacy of these two agents in cardiac surgery patients. This research proposal outlines a comparative study between dexmedetomidine and melatonin in preventing postoperative delirium in cardiac surgery patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
60.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Age more than or equal to 60 years 2.Patients scheduled for elective cardiac surgery.

Exclusion Criteria

  • 1.Patient with current/past history of mental illness, neuropsychiatric disease, h/o substance abuse, alcohol dependence.
  • 2.History of known allergy to the study drugs.
  • 3.Patients who had taken drugs which may cause sedation in last 12hours.
  • 4.History of intake of antiepileptics, antianxiety drugs, hypnotics, antidepressants or antipsychotics.
  • 5.H/o OSA and diagnosed sleep disorders.
  • 6.Redo-surgeries.
  • 7.Hemodynamically unstable patients.
  • 8.Patients refusing consent for study.

Outcomes

Primary Outcomes

To compare the effectiveness of Dexmedetomidine with Melatonin vs Dexmedetomidine alone in preventing incidence of postoperative delirium in elderly patients undergoing cardiac surgery and to identify the agent that provides superior delirium prevention outcomes.

Time Frame: Delirium will be assessed using Confusion assessment method for the ICU (CAM-ICU) one day before surgery and on postoperative day 0, 1 and 2. Postoperative delirium will be defined by fulfilment of the CAM-ICU criteria which includes 1) acute onset and fluctuating symptoms, 2) inattention, and either 3) an altered level of consciousness or 4) disorganised thinking

Secondary Outcomes

  • 1.To compare the differences in the duration of delirium between patients receiving dexmedetomidine with melatonin & dexmedetomidine alone.(2.To compare duration of mechanical ventilation & ICU stay between two groups.)

Investigators

Sponsor
Sree chitra tirunal institute for medical sciences and technology
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Haritha Ravindran

Sree chitra tirunal institute for medical sciences and technology

Study Sites (1)

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