]>
IRCT20140915019185N5 IRCT 2022-02-06 Mazandaran University of Medical Sciences Evaluation of clinical effects of oral tamsulosin in reducing urinary retention after spine surgery Evaluation of clinical effects of oral tamsulosin in reducing urinary retention after spine surgery 2020-12-21 anticipated 80 Complete https://irct.ir/trial/56400 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocking method will be used for random detection. The random allocation process will be completed with Random allocation software. Accordingly, 17 blocks 6 are created with this software and samples are assigned to each of the three groups. It should be noted that in this study, the patient's informed consent form is first recorded in writing. Participants are then randomly assigned to each group. Used to hide random allocation. Patients and researchers will not know any of the group assignments, Blinding description: The SNOSE method is used to hide (blind) random allocation. This method is one of the common methods in concealing random allocation. In this method, first a random sequence is created using Random Allocation software, then based on the sample size of the study, a number of envelopes with aluminum wrappers (in order not to clarify the contents of the envelopes) are prepared and each random sequence is created ( The intervention group (control group) is recorded on a card and the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, naming on the outer surface of the envelopes is done in the same way as it was produced with the software (for example: TF8G is written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed. 3 Urinary retention. Intervention 1: Tamsulosin capsule 4 mg mg daily dose started 7 days before surgery and will continue from zero to 2 days after surgery. The type of oral capsule will be provided to the patient. Urinary retention is prescribed. Intervention 2: Placebo capsules 4 /. Mg, which was produced in the Drug Research Center of Mazandaran University of Medical Sciences in a similar way to tamsulosin capsules, started one day 7 days before surgery and will continue from zero to 2 days after surgery. Urinary retention was prescribed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Kaveh Haddadi
Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Kaveh Haddadi
Amir Mazandarani Ave
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Male and female Ability to complete the informed consent form to participate in the study Accepting the schedule of participation in the study and the time of surgery and the fact that she must remain in the hospital for at least 1 night after surgery 18 years no limit Both Sensitivity or contraindication to the use of tamsulosin Severe hypersensitivity to sulfa drugs Use of the current alpha-blocker (alphazosin, doxazosin, prazosin, terazosin, verapamil, tamsulosin) or oral alpha agonists, or the initiation of any of these drugs during the start of the intervention phase of the study, which will cause the patient to drop out. Take warfarin now Use of a Foley catheter, suprapubic catheter or urostomy Dialysis patients or patients with less than 200 cc of urine per day Predicting the patient's inability to use the drug orally after surgery Lack of conscious consent to participate in the study Patients who use a Foley catheter chronically Patients are expected to be transferred to the ICU after surgery. Patients with a history of severe heart failure or major cardiovascular events in the past 6 months Use beta-blockers, acetylcholinesterase inhibitors, or drugs that interfere with tamsulosin and betanacol. N32.0 Bladder-neck obstruction Treatment - Drugs Placebo Tamsulosin capsule 4 mg mg daily dose started 7 days before surgery and will continue from zero to 2 days after surgery. The type of oral capsule will be provided to the patient. Urinary retention is prescribed Placebo capsules 4 /. Mg, which was produced in the Drug Research Center of Mazandaran University of Medical Sciences in a similar way to tamsulosin capsules, started one day 7 days before surgery and will continue from zero to 2 days after surgery. Urinary retention was prescribed. Urinary retention rate. Timepoint: 7 days before surgery and 0 to 2 days after surgery. Method of measurement: sonography. Mazandaran University of Medical Sciences Approved 2020-11-25 Ethics Committee of Mazandaran University of Medical Sciences, Imam Khomeini Hospital, Sari Imam Khomeini Hospital, Razi Street Ethics Committee Sari Mazandaran Iran (Islamic Republic of)