Investigating the effect of melatonin and tizanidine on pain and anxiety after cataract surgery
Design
Clinical trial with control group, with factorial groups, double-blind, randomized, phase 2 on 90 patients. A dice roll was used for randomization.
Settings and conduct
This randomized study will be conducted in patients undergoing cataract surgery referred to Bandar Abbas Shahid Mohammadi Hospital. If the patients meet the criteria for entering the study, they will be divided into three groups by throwing dice, and the level of pain and anxiety will be measured in them. The participant in the present study, the researcher, and the data collector were unaware of which group the individuals belonged to
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with ASA class one and two and consent to participate in the study. Exclusion criteria: allergy to melatonin or tizanidine, history of kidney and liver disease, chronic use of narcotics and prescription of psychotropic drugs.
Intervention groups
The first intervention group: they receive 6 mg of melatonin orally. The second intervention group: they receive 4 mg tizanidine orally. The third intervention group will receive placebo as a control group.
Main outcome variables
Pain; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043737N3
Registration date:2022-12-06, 1401/09/15
Registration timing:registered_while_recruiting
Last update:2022-12-06, 1401/09/15
Update count:0
Registration date
2022-12-06, 1401/09/15
Registrant information
Name
Mehrdad Malekshoar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
mehrdad.malekshoar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of melatonin and tizanidine on pain and anxiety after cataract surgery
Public title
Investigating the effect of melatonin and tizanidine on pain and anxiety after cataract surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cataract
ASA class I or II
Consent to participate in the study
Exclusion criteria:
History of liver or kidney disease
Chronic use of narcotics
Prescribing psychotropic drugs
Allergy or any contraindication for taking any of the study drugs
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study will be randomly divided into three groups: melatonin, tizanidine, and control by throwing dice.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person participating in the present study, the researcher and the person collecting the data will be unaware of which group the people fall into.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofBandare-abbas University of Medical Sciences
Street address
Bandar Abbas University of Medical Sciences, Shahid Chamran Boulevard,Bandar Abbas
City
Bandare-abbas
Province
Hormozgan
Postal code
7914964157
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.HUMS.REC.1401.084
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H26.0
ICD-10 code description
Infantile and juvenile cataract
Primary outcomes
1
Description
Pain
Timepoint
After the operation in recovery and 24 hours after the operation
Method of measurement
Visual Analogue Scale
2
Description
Anxiety
Timepoint
After the operation in recovery and 24 hours after the operation
Method of measurement
Richmond sedation scale
Secondary outcomes
1
Description
Vital signs
Timepoint
Every five minutes until the end of the operation
Method of measurement
Monitoring
2
Description
Nausea and Vomiting
Timepoint
In recovery
Method of measurement
Questionnaire
Intervention groups
1
Description
The first intervention group: they receive 6 mg of melatonin orally 60 minutes before surgery.
Category
Treatment - Drugs
2
Description
The second intervention group: 4 mg tizanidine orally 60 minutes before surgery.
Category
Treatment - Drugs
3
Description
The third intervention group: will receive placebo orally 60 minutes before surgery as a control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Mehrdad Malek Shoar
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
Mehrdad.malekshoar@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Street address
Shahid Chamran Blvd, Bandar Abbas
City
Bandare-abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
mdmalekshoar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas University of Medical Sciences, Shahid Chamran Boulevard
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
Mehrdad.malekshoar@hums.ac.i
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas, Shahid Chamran Boulevard, Bandar Abbas University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
Mehrdad.malekshoar@hums.ac.iR
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mehrdad Malek Shoar
Position
Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bandar Abbas, Shahid Chamran Boulevard, Bandar Abbas University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964157
Phone
+98 76 3333 3280
Email
Mehrdad.malekshoar@hums.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