Determination of the Effect of Dexmedetomidine on Pain After Open Surgery of Kidney Stones
Design
In this double-blind study, 33 patients who will be candidated for renal surgery in a randomized, randomized manner were randomly assigned to two groups of control and intervention.
Settings and conduct
This study will be conducted at Mashhad University of Medical Sciences, Imam Reza Hospital and Ghaem Hospital. In this study, researchers and patients are not aware with the type of interior.
Participants/Inclusion and exclusion criteria
After approving of the Ethical Committee of the Mashhad University of Medical Sciences and consent form of patients in Imam Reza and Ghaem Hospital, patients who are candidates for open surgery of renal kidney will be included in the study.
Intervention groups
1. Intervention group: Slow infusion of 200 micrograms of dexmedmotidine
2. Control group: Slow infusion of normal saline in intravenous
Main outcome variables
Postoperative pain level based on VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N8
Registration date:2018-08-11, 1397/05/20
Registration timing:registered_while_recruiting
Last update:2018-08-11, 1397/05/20
Update count:0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Dexmedetomedin Infusion on Reducing Pain After Open Kidney Surgery
Public title
Dexmedetomedin Infusion on Reducing Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for open-renal surgery
consenting to participate in the study
age 18-65 years
ASA class 1 and 2
BMI more than 30
have not allergy to the drug
no addiction to drug or alcohol
not taking benzodiazepines permanently
Exclusion criteria:
Systolic blood pressure lower than 100
heart rate less than 60 before the injection
Hypotension or heart rate decrease by more than 30% at baseline or during the injection
History of psychological illness
Use of any analgesic drug before operation
Needing to use an additional dose of opiates of more than 20% of the standardized value in the study during anesthesia
Be longer surgery for any reason
failure to do or complete the surgery at any stage for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
The envelope method is that the envelopes are prepared and printed by a member of the research team and random numbers with the help of the Randomaize.com site and inside the envelope. The door packs will be closed and its contents are not visible from the outside. Then, the purpose of the study is explained to the person who described the conditions, and the person, if desired, signs the informed consent form and removes an envelope, then opens it and, based on the contents of the envelope, enters into the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researcher are not aware of the type of intervention.The trial was planned in such a way that neither the subjects nor the observers (researchers) know who the group is.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences; International Offic Administration Center(Qoreishi Building) ; Daneshgah St., Mashhad Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2018-06-22, 1397/04/01
Ethics committee reference number
IR.MUMS.fm.REC.1397.15
Health conditions studied
1
Description of health condition studied
Kidney surgery
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Analgesia
Timepoint
after surgery
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infusion of a dose of 200 micrograms (2 cc) of dexmedmodine was done ones before surgery.
Category
Treatment - Drugs
2
Description
Control group: infusion of 50 cc normal salinewas done ones before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Street address
Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
sabermoghaddamm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, International Office Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3843 3363
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518022711
Email
sabermoghaddamm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518022711
Email
sabermoghaddamm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Imam Reza (AS) Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518022711
Email
sabermoghaddamm@mums.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