To determine the effect of clonidine and melatonin on delirium prevention in patients undergoing major orthopedic surgeries
Design
A total of 150 patients with elective orthopedic surgery, who have been admitted to Imam Reza Hospital in Birjand, will be selected. Participants will be randomly allocated to two intervention groups and one control group, and each participant will be assigned a code (n=50 per group).
Settings and conduct
The study will be conducted in Imam Reza Hospital in Birjand during 2019 and 2020. Participants will be randomly allocated into three groups of 50. One group will receive 100 micrograms clonidine the night before surgery at bedtime and 100 micrograms 90 minutes before surgery. In the second intervention group, melatonin will be given at a dose of 5 milligrams the night before surgery at bedtime and 5 mg 90 minutes before surgery. The control group does not receive any intervention. The level of delirium in patients will be assessed on days 1, 2, and 3 after surgery using abbreviated mental test and cognitive status examination.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: Patients undergoing major elective orthopedic surgery and age above 65 years. Major exclusion criteria: abbreviated mental test score below 8; blood pressure lower than 100 millimeters of mercury; and history of depression that has resulted in hospitalization or use of psychiatric drugs.
Intervention groups
There are two intervention groups and one control group. The first intervention group will receive 100 micrograms clonidine the night before surgery at bedtime and 100 micrograms 90 minutes before surgery. In the second intervention group, melatonin will be given at a dose of 5 milligrams the night before surgery at bedtime and 5 mg 90 minutes before surgery. The control group does not receive any intervention.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N7
Registration date:2019-03-25, 1398/01/05
Registration timing:registered_while_recruiting
Last update:2019-03-25, 1398/01/05
Update count:0
Registration date
2019-03-25, 1398/01/05
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-26, 1397/12/07
Expected recruitment end date
2020-02-25, 1398/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of melatonin and clonidine in the prevention of postoperative delirium in patients undergoing major orthopedic surgeries
Public title
Effect of melatonin and clonidine on postoperative delirium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing major elective orthopedic surgery
Age above 65 years
Informed consent for participation
Exclusion criteria:
Abbreviated mental test score below 8
Blood pressure lower than 100 millimeters of mercury
History of depression that has resulted in hospitalization or use of psychiatric drugs
Dementia
History of head trauma causing hematoma or dementia
History of tumor and cerebral infarction
History of common disorders of the glands such as hyperthyroidism and hypothyroidism
Chronic metabolic disorders
History of head and neck radiotherapy
History of poisoning with heavy metals and carbon monoxide
Alcohol consumption for more than a year
Chronic liver and kidney disease
Presence of chronic infectious diseases
Consumption of psychiatric and hypnotic drugs on a regular basis
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient is assigned a code, and they will be allocated into intervention or control groups using the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
Ir.bums.rec.1397.355
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.9
ICD-10 code description
Delirium, unspecified
Primary outcomes
1
Description
Delirium
Timepoint
24, 48, and 72 hours after syrgery
Method of measurement
abbreviated mental test and mini-mental state examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (clonidine): They will receive 100 micrograms clonidine the night before surgery at bedtime and 100 micrograms 90 minutes before surgery.
Category
Prevention
2
Description
Intervention group 2 (melatonin): In this group, melatonin will be given at a dose of 5 milligrams the night before surgery at bedtime and 5 milligrams 90 minutes before surgery.
Category
Prevention
3
Description
Control group: They will receive the routine treatment of the center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Amirhosain Ebrahimi
Street address
Taleghani St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Email
amirebrahimi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Amirhosain Ebrahimi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3234 9394
Email
amirebrahimi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Aliakbar Esmaeili
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3242 5402
Email
esmaeili67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari St.,
City
Birjand,
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Fax
+98 56 3242 0447
Email
roozgar@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
When the paper extracted from the project is published and for six months
To whom data/document is available
readers of the paper
Under which criteria data/document could be used
Research purposes upon presentation of proofs
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document
email and an estimated one-week interval for response