]>
IRCT20210228050530N1 IRCT 2021-04-07 Gonabad University of Medical Sciences The effect of hyoscine and EMLA cream on Catheter related bladder discomfort (CRBD) CRBD Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort (CRBD) in patients undergoing non-urologic surgery 2021-04-21 anticipated 105 Complete https://irct.ir/trial/54719 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After obtaining written consent from the participants, the patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter C, B and A will be considered for the 2% lidocaine gel (control group), EMLA and Hyoscine + lidocaine groups, respectively. Possible modes in permutation blocks method are six modes include (BCA, ACB, ABC, BAC, CBA, and CAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then 35 mode is selected by using a table of random numbers, 35 numbers between 1 and 6 will be selected. The resulting blocks will be listed in order. Then, based on the list, the selected patients are divided into three groups. In order to homogenize the gender, a separate list is prepared for each of those, Blinding description: Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and two intervention groups. The participants will be explained that they will allocate into two interventions or control groups. At the end of the study, they are informed about their group. The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups. One, two and three will assign to two interventions and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code. 3 Catheter related bladder discomfort. Intervention 1: Intervention group 1: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery. Intervention 2: Intervention group 2: 5 g of EMLA cream made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery. Intervention 3: Control group: 5 g lidocaine jell made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery. Yes - There is a plan to make this available What will be shared: Thesis report All research information will be published after being unidentified. When: Since 1401 To whom: Everyone can request research results. Conditions: Upon formal request through other members of the research team Where to obtain: Library of Gonabad University of Medical Sciences How to obtain: An official request to Gonabad University of Medical Sciences Comments:
public Faezeh Khajeh
No. 36, Alley 5, Resalat St.
Gonabad Iran (Islamic Republic of) 9691637744 +98 51 5725 3729 fa.freedman1992@gmail.com Gonabad University of Medical Sciences scientific Faezeh Khajeh
No. 36, Alley 5, Resalat St.
Gonabad Iran (Islamic Republic of) 9691637744 +98 51 5725 3729 fa.freedman1992@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Having ASA class 1 or 2 according to the anesthesiologist record Age between 18 and 60 years Elective surgery with general anesthesia and requires urinary catheterization No history of bladder obstruction, overactive bladder, severe kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine No cardiac dysrhythmia No obvious cognitive impairment Do not take sedatives for a long time No kidney or liver failure No history of drug use No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure Medications used before and during anesthesia should be the same 18 years 60 years Both Unwillingness to cooperate Patients should also undergo urological surgery during the operation. Any effective intervention or medication in addition to medications used in the routine anesthesia process N32.8 Other specified disorders of bladder Prevention Prevention Prevention Intervention group 1: Hyoscine N-butyl bromide made in Iran, Elixir Company, at a dose of 20 mg intravenously within one minute before extubating of a patient under non-urological surgery. Intervention group 2: 5 g of EMLA cream made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery Control group: 5 g lidocaine jell made in Iran, Iran Daroo Company before placing a urinary catheter for a patient undergoing non-urological surgery Incidence of Catheter related bladder discomfort. Timepoint: In one, two, three and four hours after the end of anesthesia. Method of measurement: Checklist for the incidence of Catheter related bladder discomfort. Severity of CRBD. Timepoint: In one, two, three and four hours after the end of anesthesia. Method of measurement: Checklist of severity of CRBD of Catheter related bladder discomfort. Gonabad University of Medical Sciences Approved 2021-02-27 Ethics committee of Gonabad University of Medical Sciences No. 36, Alley 5, Resalat St Gonabad Razavi Khorasan Iran (Islamic Republic of)