]>
IRCT20180421039368N1 IRCT 2018-06-20 Yazd University of Medical Sciences Effect of Hyoscine on Peristaltism and Cardiovascular Outcomes 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 2018-06-05 anticipated 350 Complete https://irct.ir/trial/30719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients were randomized to two groups by Simple randomization method using computer-generated random numbers, 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. 3 Patients with underlying gallbladder and biliary tract disease. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: all the data can be share after blinding the patients When: after publishing the results of study will be available To whom: all of the researchers can access to study's data Conditions: all the data will usable for analysis and comparison Where to obtain: requistion must be send by an email to the corespondent author co respondent author : dr hassan salmanroghani email: h.salmanroghani@ssu.ac.ir How to obtain: after sending request email to corespondent author, data of study will send to applier Comments:
public hassan salmanroghani
ebn sina blvd
yazd Iran (Islamic Republic of) 8915814739 +98 35 3822 4000 h.salmanroghani@ssu.ac.ir Yazd University of Medical Sciences scientific hassan salmanroghani
ebn sina blvd
yazd Iran (Islamic Republic of) 8915814739 +98 35 3822 4000 h.salmanroghani@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) age above 18 years Underlying disease needs cholangiopancreatography Existence of Duodenal peristaltism that Interference with canolation 18 years 80 years Both 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 K80-K87 Disorders of gallbladder, biliary tract and pancreas Treatment - Drugs Treatment - Drugs 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. 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. 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). 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. Yazd University of Medical Sciences Approved 2018-03-12 Ethics commitee of yazd University of Medical Sciences Ebn sina blvd, Shahid sadoughi hospital Yazd Yazd Iran (Islamic Republic of)