Aim of this study comparison effects of Melatonin premedication on Propofol and induction dose in abdominal surgery
Design
This study is clinical trial and double blind.88 patients candidate abdominal surgery in Valiasr hospital will inter this study.We divided patients in two groups by simple randomization.
Settings and conduct
This study is clinical trial and double blind.88 patients candidate for abdominal surgery entered the study in Valiasr hospital.This study is double blind.Outcome assessor and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.We divide patients in two groups randomly.We inject 3 milligram Melatonin sublingual50 minute before surgery in intervention group .We inject placebo 50 minute before surgery in control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 15-55 years, non-emergency abdominal surgery, surgery time 30 minutes to 1 hour and a half, body mass index 19 to 25, no drug use during the past week, no use of benzodiazepine-derived drugs over the past 72 hours
Exclusion criteria: dissatisfaction
Intervention groups
We inject 3 milligram Melatonin sublingual (Canadian manufacturer Inter natural - 3 milligrams) 50 minute before surgery in intervention group ( volume is brought to 3 milliliter).We inject placebo 50 minute before surgery in control group ( volume is brought to 3 milliliter).
Main outcome variables
Anxiety, awareness, sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N98
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
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
2017-04-04, 1396/01/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Melatonin premedication on Propofol and induction dose in abdominal surgery
Public title
Comparison effects of Melatonin premedication on Propofol and induction dose in abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
15-55 years
Non-emergency abdominal surgery
Surgery time 30 minutes to 1 hour and a half
body mass index 19 to 25
No drug use during the past week
No use of benzodiazepine-derived drugs over the past 72 hours
Exclusion criteria:
Dissatisfaction
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number in division of groups in two groups A and B.Patients are divide in two groups randomly.The random sequence is parallel.
Randomization method: Simple randomization.
Random unit: Individual.
Randomization Tool: Random Number Tables.
How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome assessor and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping. Outcome assessor isn't aware of grouping. Analyzer and outcome assessor know the groups in the form A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.ARAKMU.REC.1395.432
Health conditions studied
1
Description of health condition studied
abdominal surgery
ICD-10 code
R40.4
ICD-10 code description
Transient alteration of awareness
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Visual analog scale
2
Description
Awareness
Timepoint
before and after intervention
Method of measurement
Visual analog scale
3
Description
sedation
Timepoint
before and after intervention
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 3 milligram Melatonin sublingual (Canadian manufacturer Inter natural - 3 milligrams) 50 minute before surgery (volume is brought to 3 milliliter).
Category
Treatment - Drugs
2
Description
control group: We inject placebo 50 minute before surgery ( volume is brought to 3 milliliter).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Afsaneh Norouzi
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street