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IRCT20160103025821N6 IRCT 2019-03-14 Tabriz University of Medical Sciences Evaluation of the Effect of Intradermal Dihydroquin Dos on Providing Sedation for Patients with Digestive Disease A Prospective, Multicenter, Randomized, Evaluation of the Efficacy of Intranasal Administration of PCDX in Providing Moderate Sedation for Patients Undergoing Gastrointestinal Endoscopic Procedures 2018-04-19 anticipated 1650 Complete https://irct.ir/trial/37812 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: These patients are randomly divided into two treatment groups: (825) patients in the PCDX group and (825) patients in the control group will be included in the study. Randomization is categorized by research experts and reported monthly to the central research team, Blinding description: In each clinical setting, patients are randomly assigned to one of the two treatments by the pharmacist. Gastroenterologists are registered nurses who are invited to receive anesthesia and anesthetist who may be required to manage airways, an examiner assessing the patient before discharge, and statisticians blind to the treatment used. The pharmacist randomly prescribes a drug to each patient and the patients are divided into two groups.  First, in all subjects with maximum sterile precautions, it is taken in the venous route and then given to a patient randomly. Monitoring of electrocardiogram Lead II, pulse oximetry and NIBP monitoring of blood pressure. Basic signs are recorded. Excess oxygen is provided through a nasal cannula with an oxygen flow of 2 liters per minute. To prevent dryness of the nasal mucosa, excessive flow will be prevented. The nurse will prescribe the drug in the nose 20 minutes before the procedure. Both the patient (the patient and the nurse) are blinded to treatment. N/A Effect of Intradermal Dosage Injection (PCDX). Intervention 1: Intervention group: Intervention group: First, in all subjects with maximum sterile precautions, it is taken in the intravenous route and then given to a patient randomly. Monitoring of electrocardiogram Lead II, pulse oximetry and NIBP monitoring of blood pressure. Basic signs are recorded. Excess oxygen is provided through a nasal cannula with an oxygen flow of 2 liters per minute. To prevent dryness of the nasal mucosa, excessive flow will be prevented. The nurse will prescribe the drug in the nose 20 minutes before the procedure. Both the patient (the patient and the nurse) are blinded to treatment. The dose (volume) of the drug is 10 micrograms per kilogram of body weight, for example, a person will receive 100 kg of a total of 1 ml of the drug in the nose. Larger volumes can be divided into two equal doses that are prescribed in each nostril. Patients will be monitored continuously and recorded every 5 minutes with vital signs and oxygen saturation (SpO2). In this protocol, patients are monitored for moderate stenosis. After transferring patients to the endoscopy suite, a combination of midazolam, short acting benzodiazepine (initial dose of 15 μg / kg) and fentanyl citrate, a short opioid (initial dose of 0.3-0.50 μg / kg), are administered. Using the Richmond Sedation Scale (RASS), the stenting rate is considered between 1 and 2. After each dose of intravenous administration (I.V.), injector 5 ml of normal saline is injected to ensure that the drug is delivered completely. The interval between two doses will not be less than 2 minutes. Based on clinical signs and symptoms, if a suspected airway obstruction or respiratory depression is present, the nurse or gastroenterologist will stop this procedure and use airborne avionics Neck, mouthwash, and then manually ventilated with a mask to facilitate breathing. If these efforts fail, an anesthetist will help the patient with more aggressive interventions, such as laryngeal mask surgery (LMA), or intraocular tubes and positive pressure ventilation. Only clinicians using medication can do this. These providers are trained to manage emergency airways until they are contacted by an anesthetist to control airway and mechanical ventilation. Symptoms and signs for airway obstruction include: the absence of exhaled endogenous carbon dioxide, the use of minor respiratory muscles. If needed, a rescue syringe of propofol 2 mg / kg is used. In the event of hypotension, normal serum saline and vasopressor agents will be used as needed. For bradycardia, 0.5 mg of Atropine is used. After endoscopy, patients will be transferred to post-anesthetic care rooms and will be recruited by skilled nursing staff. Signs, breathing, and discomfort are constantly monitored and recorded in these units until patients have hospital clearance criteria. Modified Aldrete scoring system is commonly used in these patients to determine the clearance. Scores> 9 are considered to be cleared (Table 1). 1. Return of knowledge and activity level to preoperative level. 2. Blood pressure of about 20% of base line. 3. Respiratory tract in 20% of baseline. 4. Pain level. 4 at the reported numerical score (NRS) 5- Minimal nausea and vomiting after the fluids (PO) and vomiting to the physician 6 - The ability to walk with a low vertigo, sitting without help in your preoperative condition 7 - When a reversing factor Long-term monitoring (at least two hours) is recommended from the time of prescribing. Intervention 2: The pharmacist will conduct a randomized research, and the drug will submit the study to the GI collection. The drugs are PCDX 0.1 μg / ml or normal saline (PLCB). 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 No more information
public Dr. Hojjat Pourfathi
No32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
Tabrzi Iran (Islamic Republic of) 34424882 +98 914 313 8969 pourfathih@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Hojjat Pourfathi
No.32,University Ave, Opposite the Central Office of Tabriz University of Medical Sciences,Tabriz Town,IRAN
Tabriz Iran (Islamic Republic of) 34424882 +98 914 313 8969 pourfathih@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Symptoms of diagnostic and endoscopic interventions of upper or lower GI procedures, or both Male and female at least 18 years old Otherwise, the patient is healthy or ill with mild systemic disease, which is well controlled Urinalysis or pregnancy serum in female patients at the start of the study Being able to provide informed consent is signed 18 years no limit Both Patients under the age of 18 years or those unable to sign an informed consent Surgical procedures or those who have had an open surgical procedure for endoscopic surgery within one week Chronic opioid use or benzodiazepine for anxiety, insomnia and chronic pain Severe hyperactivity (heart rate <45 bpm) Low blood pressure (systolic blood pressure less than 90 mmHg) Advanced heartbeats, AV blocks, second and third grade, and a branch block of the sinusoidal bacillary block that is detected during the monitoring stages in the EKG, which lasts for more than 15 seconds The chronic use of beta blockers, the calcium channel block, which may cause chronic diarrhea and life threatening bradycardia Detection of ECG 12 Lead by QT. The patient will typically not be screened for this variable Patients with upper and lower GI bleeding and patients with unstable hemodynamics Pregnant pregnant women Patients with advanced liver failure Patients who have been treated with any drug in the last 30 days Undesirable reactions to medications or predscheks in previous use History of mental disorder or use of psychiatric drugs Patients with pain in the intestinal tract Gastrectomy history There may be serious illnesses simultaneously (K50-K52) Diseases of the digestive system Treatment - Drugs Placebo Intervention group: Intervention group: First, in all subjects with maximum sterile precautions, it is taken in the intravenous route and then given to a patient randomly. Monitoring of electrocardiogram Lead II, pulse oximetry and NIBP monitoring of blood pressure. Basic signs are recorded. Excess oxygen is provided through a nasal cannula with an oxygen flow of 2 liters per minute. To prevent dryness of the nasal mucosa, excessive flow will be prevented. The nurse will prescribe the drug in the nose 20 minutes before the procedure. Both the patient (the patient and the nurse) are blinded to treatment. The dose (volume) of the drug is 10 micrograms per kilogram of body weight, for example, a person will receive 100 kg of a total of 1 ml of the drug in the nose. Larger volumes can be divided into two equal doses that are prescribed in each nostril. Patients will be monitored continuously and recorded every 5 minutes with vital signs and oxygen saturation (SpO2). In this protocol, patients are monitored for moderate stenosis. After transferring patients to the endoscopy suite, a combination of midazolam, short acting benzodiazepine (initial dose of 15 μg / kg) and fentanyl citrate, a short opioid (initial dose of 0.3-0.50 μg / kg), are administered. Using the Richmond Sedation Scale (RASS), the stenting rate is considered between 1 and 2. After each dose of intravenous administration (I.V.), injector 5 ml of normal saline is injected to ensure that the drug is delivered completely. The interval between two doses will not be less than 2 minutes. Based on clinical signs and symptoms, if a suspected airway obstruction or respiratory depression is present, the nurse or gastroenterologist will stop this procedure and use airborne avionics Neck, mouthwash, and then manually ventilated with a mask to facilitate breathing. If these efforts fail, an anesthetist will help the patient with more aggressive interventions, such as laryngeal mask surgery (LMA), or intraocular tubes and positive pressure ventilation. Only clinicians using medication can do this. These providers are trained to manage emergency airways until they are contacted by an anesthetist to control airway and mechanical ventilation. Symptoms and signs for airway obstruction include: the absence of exhaled endogenous carbon dioxide, the use of minor respiratory muscles. If needed, a rescue syringe of propofol 2 mg / kg is used. In the event of hypotension, normal serum saline and vasopressor agents will be used as needed. For bradycardia, 0.5 mg of Atropine is used. After endoscopy, patients will be transferred to post-anesthetic care rooms and will be recruited by skilled nursing staff. Signs, breathing, and discomfort are constantly monitored and recorded in these units until patients have hospital clearance criteria. Modified Aldrete scoring system is commonly used in these patients to determine the clearance. Scores> 9 are considered to be cleared (Table 1). 1. Return of knowledge and activity level to preoperative level. 2. Blood pressure of about 20% of base line. 3. Respiratory tract in 20% of baseline. 4. Pain level. 4 at the reported numerical score (NRS) 5- Minimal nausea and vomiting after the fluids (PO) and vomiting to the physician 6 - The ability to walk with a low vertigo, sitting without help in your preoperative condition 7 - When a reversing factor Long-term monitoring (at least two hours) is recommended from the time of prescribing The pharmacist will conduct a randomized research, and the drug will submit the study to the GI collection. The drugs are PCDX 0.1 μg / ml or normal saline (PLCB). Low blood pressure. Timepoint: mmediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Monitoring, Sphygmomanometer tool. Nausea. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Ask the patient. Tabriz University of Medical Sciences Approved 2019-02-04 Ethics Committee of the Research and Technology department, Tabriz University of Medical Sciences Research Department, Daneshghah Ave, Tabriz Town Tabriz East Azarbaijan Iran (Islamic Republic of)