Preventing post-surgery confusion by comparing two approaches using dexmedetomidine and melatonin

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. - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083309

Enrollment

134

Registered

2025-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: T.Melatonin: T.Melatonin along with Inj. Dexmedetomidine is used in preventing delirium.T. Melatonin 6mg is given the night before surgery and continued for 3 days, post operative day 0

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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	—

Measure

Time frame

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.Timepoint: 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

Measure	Time frame
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. 3.To compare sleep disturbance, cognitive dysfunction & sedation level among both the groups. 4.To compare the total requirement of haloperidol drug in both groups. Timepoint: Postoperative agitation will be noted based on Ramsay Sedation Score on the pre operative day,postoperative day 0, 1 & 2. Post Operative Cognitive Dysfunction will be defined as a reduction in MMSE score less than 23, noted on pre operative day, post op day 0,1 & 2. Any requirement of sedatives like midazolam, antipsychotics like haloperidol in the postoperative period on day 0, 1 & 2 shall be noted. Duration of mechanical ventilation, length of ICU stay shall also be noted.	—

Measure

Time frame

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. 3.To compare sleep disturbance, cognitive dysfunction & sedation level among both the groups. 4.To compare the total requirement of haloperidol drug in both groups. Timepoint: Postoperative agitation will be noted based on Ramsay Sedation Score on the pre operative day,postoperative day 0, 1 & 2. Post Operative Cognitive Dysfunction will be defined as a reduction in MMSE score less than 23, noted on pre operative day, post op day 0,1 & 2. Any requirement of sedatives like midazolam, antipsychotics like haloperidol in the postoperative period on day 0, 1 & 2 shall be noted. Duration of mechanical ventilation, length of ICU stay shall also be noted.

—

Countries

India

Contacts

Public ContactDr Haritha Ravindran

Sree chitra tirunal institute for medical sciences and technology

suneel@sctimst.ac.in7708190480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026