Melatonin versus Alprazolam in elderly heart surgery patients: Effects on anxiety, blood sugar and heart.

Oral Melatonin versus Oral Alprazolam premedication in geriatric cardiac surgical patients: Comparative assessment of anxiolytic, sedative, glycemic and cardioprotective effects- A Randomized Controlled Study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099894

Enrollment

100

Registered

2025-12-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: I252- Old myocardial infarction

Interventions

Intervention1: GROUP M (MELATONIN): The patients allocated in this group will receive 3 mg oral Melatonin night before the surgery and on the day of the surgery(2 hours prior to surgery) and will be f

Eligibility

Inclusion criteria

Inclusion criteria: GERIATRIC PATIENTS( MORE THAN OR EQUAL TO 65 YEARS) UNDERGOING ELECTIVE CARDIAC SURGERY ASA CLASS II - IV

Exclusion criteria

Exclusion criteria: GERIATRIC PATIENTS UNDERGOING EMERGENCY CARDIAC SURGERY KNOWN ALLERGY TO MELATONIN OR ALPRAZOLAM PATIENTS WITH SLEEP DISTURBANCES PATIENTS ON MELATONIN SUPPLEMENTATION

Design outcomes

Primary

Measure	Time frame
PREOPERATIVE ANXIETY USING AMSTERDAM PREOPERATIVE ANXIETY AND INFORMATION SCALETimepoint: BASELINE (DAY BEFORE SURGERY) AND 2 HOURS AFTER PREMEDICATION (ON THE DAY OF SURGERY).	—

Secondary

Measure	Time frame
LEVEL OF SEDATION USING RAMSAY SEDATION SCALE AND BISPECTRAL INDEX VALUETimepoint: BASELINE (DAY BEFORE SURGERY) AND 2 HOURS AFTER PREMEDICATION (ON THE DAY OF SURGERY);HS-TROP I, HS-CRPTimepoint: BASELINE , 24 HOURS AND 48 HOURS POSTOP;DURATION OF MECHANICAL VENTILATION, LENGTH OF ICU STAY, NEW ONSET ARRHYTHMIASTimepoint: POSTOP DAY 1, 3 AND 5;PATIENT SATISFACTION LEVEL AND SLEEP QUALITYTimepoint: 2 HOURS AFTER PREMEDICATION(ON THE DAY OF SURGERY);BLOOD GLUCOSE LEVELSTimepoint: BASELINE, DAY 1, DAY 2, DAY 3	—

Measure

Time frame

LEVEL OF SEDATION USING RAMSAY SEDATION SCALE AND BISPECTRAL INDEX VALUETimepoint: BASELINE (DAY BEFORE SURGERY) AND 2 HOURS AFTER PREMEDICATION (ON THE DAY OF SURGERY);HS-TROP I, HS-CRPTimepoint: BASELINE , 24 HOURS AND 48 HOURS POSTOP;DURATION OF MECHANICAL VENTILATION, LENGTH OF ICU STAY, NEW ONSET ARRHYTHMIASTimepoint: POSTOP DAY 1, 3 AND 5;PATIENT SATISFACTION LEVEL AND SLEEP QUALITYTimepoint: 2 HOURS AFTER PREMEDICATION(ON THE DAY OF SURGERY);BLOOD GLUCOSE LEVELSTimepoint: BASELINE, DAY 1, DAY 2, DAY 3

—

Countries

India

Contacts

Public ContactDr ROJA EMANI

ALL INDIAN INSTITUTE OF MEDICAL SCIENCES

sambhunathds833@gmail.com7036004706

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026