To investigate the effect of modafinil for prevention of cognitive and sociological dysfunction after sleeve gastrectomy
Design
Double Blinded Randomized Clinical Trial
Settings and conduct
80 patients undergoing sleeve gastrectomy are divided into two groups of 40.patients in the first group received 2 tablets of modafinil 100 mg two hours before the operation and patients in the second group received 2 tablets of placebo two hours before the operation.
The investigator determines the type of drug or placebo and provides them to the nurse for prescribing to the patient. The patient and the person evaluating the patient after the surgery are unaware of the type of intervention.
The patients will be evaluated the day before the surgery and after leaving the recovery room by two tests of Addenbrooke's Cognitive Examination (ACE) for Cognitive problems and also Depression and Anxiety Scale, DASS-21 for Depression and Anxiety.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who are candidate for elective sleeve gastrectomy ASA I-II age between 18-45 years’ old.
Exclusion criteria:Active and uncontrolled diseases of the cardiovascular system; Gastrointestinal diseases; Liver and kidney Diseases; Psychological and mental illness; Neurological diseases; Taking psychiatric medications; opium addiction.
Intervention groups
patients in the first group received 2 tablets of modafinil 100 mg two hours before the operation and patients in the second group received 2 tablets of placebo two hours before the operation.
Main outcome variables
Depression and Anxiety and Cognitive problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N76
Registration date:2018-09-06, 1397/06/15
Registration timing:registered_while_recruiting
Last update:2018-09-06, 1397/06/15
Update count:0
Registration date
2018-09-06, 1397/06/15
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-02-25, 1397/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of modafinil for prevention of cognitive and sociological dysfunction after sleeve gastrectomy
Public title
Effect of modafinil for prevention of cognitive and sociological dysfunction after sleeve gastrectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for elective sleeve gastrectomy
ASA I-II
age between 18-45 years old
Exclusion criteria:
Active and uncontrolled diseases of the cardiovascular system.
Gastrointestinal diseases.
Liver disease.
kidney Diseases.
Psychological and mental illness.
Neurological diseases.
Taking psychiatric medications.
opium addiction
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized according to the charts which was derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator determines the type of drug or placebo based on the randomized list and provides drug or placebo to the nurse in the ward for prescribing to the patient. The patient and the person evaluating the patient after the surgery are unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1396.63
Health conditions studied
1
Description of health condition studied
sleeve gastrectomy
ICD-10 code
K95.89
ICD-10 code description
Other complications of other bariatric procedure
Primary outcomes
1
Description
Depression and Anexiety
Timepoint
The day before the surgery and after leaving the recovery room.
Method of measurement
Depression and Anxiety Scale, DASS-21
2
Description
Cognitive problems
Timepoint
The day before the surgery and after leaving the recovery room.
Method of measurement
The Addenbrooke's Cognitive Examination (ACE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:patients received 2 tablets of modafinil 100 mg two hours before the operation.
Category
Prevention
2
Description
Control group: patients received 2 tablets of placebo two hours before the operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother and Child Hospital
Full name of responsible person
Kambiz Golestani
Street address
Mother and Child Hospital, Quran square, Emam Reza boulevard,
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Kambiz Golestani
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrdad Salari
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in English Teaching, BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
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