Double-blind randomized clinical trial with control group and parallel group design, randomization with random block method, With a sample size of 72.
Settings and conduct
In this prospective, double-blind, randomized study, 72 patients over 60 years of age undergoing femoral bone fractures or knee arthroplasty or hip joint surgery with a spinal anesthesia hospitalized in Shahid Beheshti Hospital of Kashan were included. Patients were randomly divided into two groups: the patients in the melatonin group received oral 5 mg melatonin a night before the operation and the control group received placebo. The Abbreviated Mental Test (AMT) was used to detect delirium. The delirium test was performed by the checklist three days after the operation and the patient's AMT score was recorded. If the score was below 8, the delirium was considered to be positive. The obtained data included the demographic characteristics of the patients, the type of operation, and the results of the AMT test in the questionnaire. The data were entered into the SPSS software and finally analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients over 60 years;
Under orthopedic surgery;
Under spinal anesthesia.
Non-inclusion criteria:
History of drug abuse;
Sensory loss including deafness and blindness;
Dementia;
History of seizures.
Intervention groups
In the intervention group, the night before surgery and until three nights later operation, every night the melatonin capsule will be given; and for placebo group, the night before surgery and until three nights after operation, the placebo capsule will be given every night.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190419043320N1
Registration date:2019-05-20, 1398/02/30
Registration timing:prospective
Last update:2019-05-20, 1398/02/30
Update count:0
Registration date
2019-05-20, 1398/02/30
Registrant information
Name
Saba Mofidian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5542 1451
Email address
mofidian-s@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-28, 1398/03/07
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing melatonin and placebo in prevention of postoprative delirium after orthopedic surgery under spinal anesthesia in the elderly.
Public title
The effect of Melatonin on Delirium Prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over the age of 60 under hip, femure or knee surgery
Surgery under spinal anesthesia
Exclusion criteria:
Drug abuse
Dementia
Sensory loss including blindness and deafness
Epilepsy
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method was used. First we designed blocks of size 4 of A&B in which one of them indicated drug & one of them indicated placebo. Then based on random numbers we wrote a sequence of A&B. Patients were allocated to the groups based on the sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient, person who give the drug to patient ,nurses and the person who evaluates delirium do not know which group the patient is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotberavandi Blv, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.007
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05.8
ICD-10 code description
Other delirium
Primary outcomes
1
Description
Delirium
Timepoint
At the beginning of the study and T the first, second and third days after the intervention
Method of measurement
MMT Test Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One melatonin 5-milligram capsule; night before surgery and the night of surgery and two nights later (one capsule every night)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Beheshti Hospital
Full name of responsible person
Dr Saba Mofidian
Street address
Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
mofidian-s@mail.kaums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences, Ghotberavandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mofidian-s@mail.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Position
Vice Chancellor of Research & Technology
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Kashan University of Medical Science, Ghotberavandi Blv
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
banafshe_h@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saba Mofidian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Diba 5th, Sanat Blv
City
Kashan
Province
Isfehan
Postal code
8714881998
Phone
+98 31 5542 1451
Email
mofidian-s@mail.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saba Mofidian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Diba 5th, Sanat Blv
City
Kashan
Province
Isfehan
Postal code
8714881998
Phone
+98 31 5542 1451
Email
mofidian-s@mail.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available