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IRCT20100102002963N36 IRCT 2022-09-13 Yazd University of Medical Sciences Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients who are candidates for upper gastrointestinal endoscopy. Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients candidates for upper gastrointestinal endoscopy 2022-09-23 anticipated 80 Complete https://irct.ir/trial/65210 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly divided into two groups of 40 people in such a way that using the Random allocation software version 1.0 under Windows, we generate a random sequence using a simple random allocation method. In this table, numbers from 1 to 80 are specified and each number is assigned to an intervention group (A or B). Number 1 is assigned to the first qualified person, second person is number 2, and so on up to 80 patients. becomes Then based on the random allocation list prepared and by the software, it is determined which group A or B each person is placed in. All patients receive drugs and placebo (normal saline) both intravenously and sublingually. Each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug and placebo are given to the patients by a third person who is not involved in evaluating the patients and recording the results, Blinding description: The patients themselves and the researcher are not aware of the dose and method in which the patient received the drug, as all patients receive the drug and placebo (normal saline) both intravenously and sublingually. They do not know in which method the drug and which placebo is prescribed for each patient. Each drug is placed in a package and the packages are coded, and based on the table of random numbers and specified code, the drug is given to the patients by a third person who is not involved in evaluating the patients and recording the results. 2 The effect of medicine on the level of sedation, pain and discomfort and satisfaction of patients who are candidates for upper gastrointestinal endoscopy. Intervention 1: Intervention group: Before the procedure, patients are given 2.5 mg of intravenous midazolam and 1 ml of normal saline sublingually. Intervention 2: Intervention group: Patients are given one milliliter of normal intravenous saline and 5 mg of midazolam sublingually before the procedure. 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 I haven't decided yet. Its subscription schedule is not yet known
public Dr. Shekoufeh Behdad
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3823 1932 drbehdad@ssu.ac.ir Yazd University of Medical Sciences scientific Dr. Shekoufeh Behdad
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3822 4101 drbehdad@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Adult patients who are candidates for upper gastrointestinal endoscopy who undergo diagnostic endoscopy for the first time 15 years 55 years Both Existence of moderate to severe systemic disease history of using of sedative or tranquilizer drugs addiction to opioids or any sedative or psychotropic drugs disagreement for cooperation in this study Treatment - Drugs Treatment - Drugs Intervention group: Before the procedure, patients are given 2.5 mg of intravenous midazolam and 1 ml of normal saline sublingually Intervention group: Patients are given one milliliter of normal intravenous saline and 5 mg of midazolam sublingually before the procedure. The level of sedation. Timepoint: Before endoscopy. Method of measurement: A sedation score from 1 to 6 is given to each patient. In this way, score 1: the patient is awake, anxious and restless. Score 2: The patient is awake, alert, calm and cooperative. Score 3: The patient is awake and obeys orders. Score 4: The patient is asleep and responds quickly to stimulation (gentle blow to the forehead or loud sound stimulation). Score 5: The patient is asleep and gives a weak response to stimulation (gentle blow to the forehead area or loud sound stimuli). Score 6: The patient is asleep and does not respond to stimulation (gentle blow to the forehead area) or loud sound. The level of Pain/discomfort. Timepoint: Before endoscopy. Method of measurement: Pain/discomfort Score(0-10). The level of satisfaction that gave a score of 1 to 10 for each patient. Timepoint: Before endoscopy. Method of measurement: Satisfaction Score(0-10). Yazd University of Medical Sciences Approved 2018-12-26 Ethics Committee of Shahid Sadoughi University of Medical Sciences Central building of Yazd University of Medical Sciences, Bahonar Square Yazd Yazd Iran (Islamic Republic of)