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
In this double blinds clinical trial, 80 patients who are candidate for coronary artery bypass grafts in ICU open heart surgery ward get to study serially if they will be satisfied to cooperate in this study. 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.
After personal information questionnaire (proposal index ) completion for all patients, the patients will be assigned to two groups randomly that includes melatonin tablet receivers and lorazepam tablet receivers. In the morning of hospitalization day, 5 cc venous blood samples will be taken from all the patients in this study to assess blood levels of leptin, melatonin and cortisol.
The patients of two groups will take 3mg melatonin tablet for four nights at 21 o'clock of every night (for 40 patients of first group from second day to fifth stay day )and 2 mg lorazepam tablet for four nights at 21 o'clock of every night (for 40 patients of second group from second day to fifth stay day ). After four nights, 5 cc venous blood samples will take from all patients to measure serum levels of leptin, melatonin and cortisol.
Standard Sleep Disorders Questionnaire (SSS) is used to assess quality of sleep at former night of operation and fourth night of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082523760N1
Registration date:2016-10-25, 1395/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Mohammad Reza Jamshidi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 334 6346
Email address
jamshidianes@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-02-17, 1395/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of melatonin tablet on sleep disorders in patients in cardiac surgery intensive care unit
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double blind clinical study (patients and researcher).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.