The Preventive Effect of Administration of Dexmedetomidine or Ketamine in the Control of Postoperative Gastroparesis Laparoscopic Surgery
Design
three arm parallel groups, double blinded, randomized controlled trial
Settings and conduct
Double-blinded study, intervention groups were not aware of the placement of the groups as well as those who participated in the gathering of information, will not be inform about the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 18 and under 50 years old;
Body mass index greater than 35;
Patients with grade 1 or 2 ASA;
Non-development of neurological disorders;
Exit criteria:
Drug allergy;
Blood pressure less than 90 mm Hg;
A disease that is difficult to detect;
Intervention groups
The first group consists of 40 patients who will receive 1 mg / kg of ketamine 10 minutes before anesthesia induction. The second group will consist of 40 patients who receive 0.5 mg / kg of Dexmedetomidine for 10 minutes before anesthesia induction. The control group will include 40 people who will not receive any of the previous treatments.
Main outcome variables
Patient's pain during recovery using VAS measurement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N29
Registration date:2019-05-01, 1398/02/11
Registration timing:registered_while_recruiting
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of Ketamine or Dexmedetomidine in the control of postoperative pain after Laparoscopic Gastric Bypass Surgery
Public title
Preventive effect of Ketamine or Dexmedetomidine in the control of postoperative pain after Laparoscopic Gastric Bypass Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 and under 50 years old
Body mass index greater than 35
Patients with ASA grade 1 or 2
Lack of neurological disorders.
Lack of heart disease or lung disease
No addiction
Exclusion criteria:
drug reaction
Blood pressure less than 90 mm Hg
patient who Intubated hard
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization block, randomization unit: Individual, Random layer: not done Randomization, tool: Random sequence generation software (Excel), How to create random sequence: Using random blocks, each block contains 4 people And assign a number from 1 to 6 to each block
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be aware of being in the study groups and collecting data will be done by people who are unaware of the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical sciences
Street address
Isfahan university of medical sciences, azadi square, Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.MUI.REC.1396.234
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Every 15 minutes until the patient leaves the recovery and in the department at 6, 12, 18, and 24 hours
Method of measurement
Using the VAS Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 1 mg per kg of ketamine 10 minutes before induction of anesthesia will be given.
Category
Treatment - Drugs
2
Description
Intervention group 2: 0.5 mg per kg of Dexmedetomidine 10 minutes before induction of anesthesia will be given.
Category
Treatment - Drugs
3
Description
Control group: None of the drugs and treatments of other groups will be received
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Dr Seyed Taghi Hashemi
Street address
Alzahra hospital, Alzahra street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
sh_f1992@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for research/Master of Science
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Research office , Al-Zahra hospital, Al-zahra street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
mehrabi@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Taghi Hashemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra Hospital, Sofeh Blvd, Isfahan
City
isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
sh_f1992@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shekofeh Enayati Ataabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Alzahra Hospital, Sofeh Blv, Isfahan, Iran
City
isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sh_f1992@yahoo.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
People who need this information
Under which criteria data/document could be used
All uses are allowed
From where data/document is obtainable
Contact with corresponding author
What processes are involved for a request to access data/document