The effect of melatonin tablet on sleep disorders in patients in cardiac surgery intensive care unit

Effect of melatonin tablets compared to lorazepam tablets on circadian rhythm of sleep and serum level of leptin and cortisole and melatonin in CABG patients admited in heart ICU ward of Mousavi hospital, Zanjan

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015082523760N1

Enrollment

Registered

2016-10-25

Start date

2016-04-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Sleep disorders. Circadian rhythm sleep disorders

Interventions

Intervention 1: Intervention group 1: 40 patient in Melatonin group will take 3 mg melatonin tablet for four nights. Intervention 2: Intervention group 2: 40 patient in Lorazpam group will take 2 mg l

Treatment - Drugs

Intervention group 1: 40 patient in Melatonin group will take 3 mg melatonin tablet for four nights

Intervention group 2: 40 patient in Lorazpam group will take 2 mg lorazepam tablet for four nights.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age older than18 years old; GCS>=10; stable hemodynamic state; no dependence on the ventilator. Exclusion criteria : pregnancy; sleep disorder; convulsion; neuropsychiatric disorders; blindness and deafness; liver and kidney disorders; CHF; gastroparesia; drugs that reduce melatonin effect; sensitivity to melatonin; worsening of overall health; earlier discharge from the sixth day.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep disorders. Timepoint: First nights and the fourth night stay. Method of measurement: Stanford Sleep Scale Questionnaire( SSS Questionnaire ).;Serum leptin level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.;Serum melatonin level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.;Serum cortisol level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.	—

Measure

Time frame

Sleep disorders. Timepoint: First nights and the fourth night stay. Method of measurement: Stanford Sleep Scale Questionnaire( SSS Questionnaire ).;Serum leptin level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.;Serum melatonin level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.;Serum cortisol level. Timepoint: Second and fifth day of hospitalization. Method of measurement: Germany laboratory elisa kits.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Afagh Anjomshoaa

Zanjan University of Medical Sciences

afagh_anjomshoaa@yahoo.com+98 24 3313 0000

Outcome results

None listed

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