Efficacy of Low Dose Hyoscine N-butyl Bromide Versus Usual Dose on Anti Motility Response and Cardiovascular Outcomes During Endoscopic Retrograde Cholangiopancreatography in patients with billiary tract disorder
Assessment the effect of low dose of hyoscine versus usual dose in anti motility response and cardiovascular outcomes during endoscopic retrograde cholangiopancreatography
Design
this is a randomized clinical trial with parallel group, double blinded study with sample size of 350 patients ( 175 patients for each group )
Settings and conduct
Yazd city, patient who come to state and private hospitals.
Physician , personnel , and data collectors are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age above 18 years,
Underlying disease needs cholangiopancreatography,
Existence of Duodenal peristaltism that Interference with canolation,
Exclusion criteria:
Previous cardiovascular problems ( heart failure, myocardial infarction, second and third degree AV block ),
Acute pancreatitis and cholangitis before procedure,
Severe hypotension ( <100 mmhg ),
Pregnancy and breastfeeding,
History of previous Allergy to Hyoscine,
Intervention groups
Group one receive 5mg (low dose) hyoscine N-butylbromide and group two ( usual dose of hyoscine ) receive 10 mg. The drug injects slowly intravenous and the spasmolytic effect of it is considered when the papilla is in enface view.
Main outcome variables
Assessment the minimum effective dose of hyoscine in anti motility and duration response , and cardiovascular outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180421039368N1
Registration date:2018-06-20, 1397/03/30
Registration timing:registered_while_recruiting
Last update:2018-06-20, 1397/03/30
Update count:0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Hassan Salmanroghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
h.salmanroghani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Low Dose Hyoscine N-butyl Bromide Versus Usual Dose on Anti Motility Response and Cardiovascular Outcomes During Endoscopic Retrograde Cholangiopancreatography in patients with billiary tract disorder
Public title
Effect of Hyoscine on Peristaltism and Cardiovascular Outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age above 18 years
Underlying disease needs cholangiopancreatography
Existence of Duodenal peristaltism that Interference with canolation
Exclusion criteria:
Previous cardiovascular problems ( heart failure, myocardial infarction, second and third degree AV block )
Acute pancreatitis and cholangitis before procedure
Severe hypotension ( <100 mmhg )
Pregnancy and breastfeeding
History of previous Allergy to Hyoscine
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
350
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were randomized to two groups by Simple randomization method using computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
in our study, we inform the patients about the necessity of hyoscine injection. The patients and physician (performing the procedure) are both blinded to the injected drug dosage (low or usual).
clinical care staff and analyzer are also blinded to the dosage of the drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of yazd University of Medical Sciences
Street address
Ebn sina blvd, Shahid sadoughi hospital
City
Yazd
Province
Yazd
Postal code
8915814739
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.262
Health conditions studied
1
Description of health condition studied
Patients with underlying gallbladder and biliary tract disease
ICD-10 code
K80-K87
ICD-10 code description
Disorders of gallbladder, biliary tract and pancreas
Primary outcomes
1
Description
comparison of anti motility duodenal response
Timepoint
Before starting the procedure, five minutes after the injection of hyoscine, and at the end of procedure
Method of measurement
observing the duodenal motility ( presence or absence of peristaltism) by physician during cholangiopancreatography (ERCP)
Secondary outcomes
1
Description
comparison of blood pressure changes, cardiac rate and rhythm and o2 satuartion changes
Timepoint
Before starting the procedure, five minutes after the injection of hyoscine, and at the end of procedure
Method of measurement
cardiac monitoring for blood pressure and heart rate and pulsoximetry for o2 saturation
Intervention groups
1
Description
Intervention group: patients who receive low dose of hyoscine N-butylbromide ( 5 mg ) from Exir pharmaceutical company during cholangiopancreatography. The frequency of drug use depends on the duration of procedure and its interference with peristaltism.
Category
Treatment - Drugs
2
Description
Control group: patients who receive usual dose of hyoscin N-butylbromide ( 10mg ) from Exir pharmaceutical company during cholangiopancreatography. The frequency of drug use depends on the duration of procedure and its interference with peristaltism.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid sadoughi hospital
Full name of responsible person
hassan salmanroghani
Street address
ebn sina blvd
City
yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
h.salmanroghani@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
dr massoud mirzaei
Street address
ebn sina blvd
City
yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
dr_smm2020@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
hassan salmanroghani
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
ebn sina blvd
City
yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
h.salmanroghani@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
hassan salmanroghani
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
ebn sina blvd
City
yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
h.salmanroghani@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyed masoud mirvakili
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
ebn sina blvd
City
yazd
Province
Yazd
Postal code
8916795594
Phone
+98 35 3822 4000
Email
dr_smm2020@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 the data can be share after blinding the patients
When the data will become available and for how long
after publishing the results of study will be available
To whom data/document is available
all of the researchers can access to study's data
Under which criteria data/document could be used
all the data will usable for analysis and comparison
From where data/document is obtainable
requistion must be send by an email to the corespondent author
co respondent author : dr hassan salmanroghani
email: h.salmanroghani@ssu.ac.ir
What processes are involved for a request to access data/document
after sending request email to corespondent author, data of study will send to applier