The effect of melatonin in the treatment of delirium in critically ill patients admitted to the intensive care unit of Vali-Asr Hospital in Arak
Design
The study will be double blind and clinical trial.80 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients diagnosed with delirium in Valiasr hospital in Arak city are divided into 2 groups by simple randomization using block method. The study is double-blind. In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the interns do not know about the prescribed drugs, and the follow-up of the patients is with the interns, and the analyst does not know about the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients diagnosed with delirium by DSM-V criteria; Age 18 to 80 years; RASS criterion greater than or equal to 3; lack of primary neurological disease such as stroke, dementia, psychosis; Absence of seizure history; The patient should not be so restless that there is a possibility of harming himself or others and it is not possible to wait for the response of oral medication; Insensitivity to drugs; ; No history of SSRI use
Exclusion criteria: non-consent of companions
Intervention groups
Intervention group 1: Patients in this group will receive 3 mg of melatonin at night for 5 days.
Intervention group 2: The patients in this group will receive haloperidol (Caspian Tahind Pharmaceutical Company, Iran) at a dose of 2.5 mg intramuscularly every 6 hours. If necessary, up to 40 mg per day can be prescribed, and if delirium is not controlled with this dose, other drugs are used and the patient is excluded from the study.
Main outcome variables
Sedation; Illness severity; Number of hospitalization days, mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N189
Registration date:2023-09-25, 1402/07/03
Registration timing:registered_while_recruiting
Last update:2023-09-25, 1402/07/03
Update count:0
Registration date
2023-09-25, 1402/07/03
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin in the treatment of delirium in critically ill patients admitted to the intensive care unit
Public title
The effect of melatonin in the treatment of delirium in critically ill patients admitted to the intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients for whom a diagnosis of delirium was made by DSM-criteria were included.
Age 18 to 80 years
RASS criterion greater than or equal to 3
Absence of primary neurological disease such as stroke, dementia, psychosis
Failure to enter patients who are in a coma for more than 24 hours and have a structural reason for their low level of consciousness
No history of seizures
Absence of underlying disease
The patient should not be so restless that there is a possibility of harming herself or others and she cannot wait for the response of oral medication.
Absence of pregnancy and breastfeeding
Insensitivity to drugs
Absence of QTc greater than 440 ms
No history of SSRI use
Exclusion criteria:
Lack of consent of the companions (the person in charge of the patient) to receive the medicine and the patient's participation in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the supervisor knows about the grouping and prescribes the drugs for the patients, and the interns do not know about the prescribed drugs, and the follow-up of the patients is with the interns, and the analyst does not know about the grouping, and as a result, the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.ARAKMU.REC.1402.114
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Sedation
Timepoint
Daily to 7 days
Method of measurement
Based on the RASS score
2
Description
Illness severity
Timepoint
Daily to 7 days
Method of measurement
Apachi score
3
Description
Number of hospitalization days
Timepoint
End of study
Method of measurement
File
4
Description
Mortality
Timepoint
End of study
Method of measurement
File
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group will receive 3 mg of melatonin at night for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: The patients in this group will receive haloperidol (Caspian Tahind Pharmaceutical Company, Iran) at a dose of 2.5 mg intramuscularly every 6 hours. If necessary, up to 40 mg per day can be prescribed, and if delirium is not controlled with this dose, other drugs are used and the patient is excluded from the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davoud Hekmatpou
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hekmatpou@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street