The effect of epidural infusion of Dexmedetomidine and Ropivacaine on erection following reconstructive urethral surgery
Design
Candidate patients for reconstructive urethral surgery were divided into two groups using computer generated simple randomization and random number generation software and each group includes 15 individuals. Groups; Dexmedetomidine group and the Ropivacaine group. Sample size 30 was determined and divided into 2 groups.Sample size 30 was determined that divided in 2 groups. Double blind Clinical trial.
Settings and conduct
all Patients candidate who fulfilled inclusion criteria for reconstructive urethral surgery in Shohadaye Tajrish Hospital divided in groups and participants have no consent about groups and medication which they received.
Participants/Inclusion and exclusion criteria
All patients between 20-60 years old candidate for reconstructive urethral surgery
Without history of cardiac disease ( Syncope, Arrhythmia and bradycardia)
Intervention groups
Two groups; The first group receive Dexmedetomidine through epidural continuous infusion pump and the second group receive Ropivacaine through epidural continuous infusion pump.
Main outcome variables
The effect of epidural Dexmedetomidine and Ropivacaine infusion on erection incidence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042569N4
Registration date:2020-08-23, 1399/06/02
Registration timing:registered_while_recruiting
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Nima saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 8939
Email address
nimasaeedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness comparison of epidural Dexmedetomidine vs Ropivacaine infusion to prevent erection following reconstructive urethral surgery
Public title
The effect of epidural infusion of Dexmedetomidine and Ropivacaine on erection following reconstructive urethral surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients between 20-60 years old candidate for reconstructive urethral surgery
Exclusion criteria:
History of cardiac disease ( Syncope, Arrhythmia and bradycardia)
History of allergic reaction to drug which is used in the study
Age
From 20 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer generated simple randomization (random number generator software) to design two groups (dexmedetomidine vs ropivacaine)
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that patients in both groups have epidural catheters and do not know which drug is used, they are blind. The anesthesiologist in charge is not aware of the patient's group and drugs that is used in infusion pump .
And the person responsible for follow-up and recordings data has no information about the patient's group and only the person responsible for preparing epidural infusion pump is aware of the patient's groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, Arabi Ave., Daneshjoo Blvd., Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.473
Health conditions studied
1
Description of health condition studied
Erection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Erection after the reconstructive urethral surgery
Timepoint
Daily for one week
Method of measurement
Questionnaire (quality and degree of erection)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: At the end of operation, the continuous infusion pump with a total volume of 100 cc containing dexmedetomidine 50 micro grams and sterile water; 6 cc per hour is connected to the epidural catheter.
Category
Prevention
2
Description
Intervention group 2: At the end of the operation, the continuous infusion pump with a total volume of 100 cc containing Ropivacaine 0.125% and sterile water; 6 cc per hour is connected to the epidural catheter.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Nima Saeedi
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziayi
Street address
Third floor, School of Medicine, Shahid Beheshti Univerity of medical science, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Fax
Email
mpd@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@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
Participant data (age, grade of erection and type of patient's group) are to be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Using data and analysis for use in academic research
From where data/document is obtainable
Send an Email to Dr.Nima Saeedi, Email Address: nimasaeedi7@yahoo.com
What processes are involved for a request to access data/document
Send request via Email and after 1 week will be replied.